Reported trial results for Colorectal Cancer

76 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05609370 · results posted 30 June 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 113 participants in total across two phases. The early phase (Phase 1b) tested three different doses of a drug called alcestobart, combined with three other medicines (tislelizumab, bevacizumab, and a chemotherapy called fluoropyrimidine), in 25 people, mainly to track unwanted medical events. The later phase (Phase 2) enrolled 88 people with a type of cancer, dividing them into groups based on whether their tumour tested positive or negative for a protein called PD-L1 (a marker sometimes used to guide treatment decisions). Phase 2 compared different drug combinations against each other, with the main thing being measured being how long participants went without their disease getting worse — known as "progression-free survival." The reported data shows that in Phase 1b, all 25 participants experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred during treatment), and 14 of the 25 experienced a serious adverse event (one serious enough to require hospitalisation, be life-threatening, or have another significant impact). For the Phase 2 PD-L1-positive groups, the reported data shows a progression-free survival figure of 4.4 months for the comparison group (bevacizumab plus chemotherapy alone), while the corresponding figure for the alcestobart combination group was not reported in the submitted data. For the PD-L1-negative groups, the reported figures were 6.5 months for the alcestobart combination group and 10.4 months for the comparison group. The reported data also shows that in the PD-L1-positive groups, 5.6% of participants in the alcestobart combination group had their tumour shrink meaningfully (a complete or partial response), compared with 0% in the comparison group. In the PD-L1-negative groups, 0% in the alcestobart combination group had such a response, compared with 4.3% in the comparison group. How long those responses lasted (duration of response) was not reported in the submitted data for any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04607421 · results posted 11 June 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04607421) enrolled a total of 841 participants across several groups and phases. It was designed to test an experimental treatment called EC (enfortumab conjugate, used alone or combined with chemotherapy regimens) against standard chemotherapy in people with a specific type of cancer. The trial ran in three main stages: a safety lead-in phase with 57 people (30 in one group, 27 in another) to check for early signs of serious side effects; a main Phase 3 comparing three arms with a combined 637 participants; and a Cohort 3 stage with 147 participants split across two further groups. The reported data shows the following numbers across the key measurements. In the safety lead-in, 1 out of 30 participants in the first group and 0 out of 27 in the second group experienced what the trial defined as a "dose limiting toxicity" — meaning a side effect serious enough, within the first 28 days, to prevent the person from tolerating the planned treatment dose. In the main Phase 3, the reported median "progression-free survival" (the length of time, on average, before a participant's disease worsened or they died) was 12.8 months for the EC plus chemotherapy arm, compared with 7.1 months for the standard chemotherapy control arm. The "objective response rate" — the percentage of participants whose tumours showed a meaningful reduction in size — was reported as 60.9% for the EC combination arm versus 40.0% for the control arm. In Cohort 3, the reported objective response rate was 64.4% for the EC plus FOLFIRI group compared with 39.2% for the FOLFIRI with or without bevacizumab group. The reported data for the secondary outcomes measuring the number of participants who experienced adverse events (unwanted medical occurrences) was not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04403022 · results posted 3 June 2026

  According to the results reported on ClinicalTrials.gov, this trial looked at a robotic surgical system called the da Vinci SP being used for two types of bowel operations: a right colectomy (removal of part of the large bowel on the right side) and a lower anterior resection (removal of part of the lower bowel). A total of 60 people took part — 29 in the right colectomy group and 31 in the lower anterior resection group. The trial was measuring two main things: whether each operation could be completed as planned without needing to switch to a different surgical approach, and how many participants experienced a major unwanted medical event within 42 days after their operation. The reported data shows that in both groups, zero participants required a switch to a different surgical approach — meaning all operations that were started with the da Vinci SP system were completed using that same approach. Regarding major unwanted medical events in the 42 days following surgery, the reported data shows that 1 participant in the right colectomy group and 3 participants in the lower anterior resection group experienced such an event. No other outcome figures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01105169 · results posted 20 February 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 250 adults who were divided into four groups based on a genetic variation (a difference in a single point in their DNA) and whether they received magnesium supplements or a dummy pill (placebo). The two genetic groups were labelled "GG" and "GA/AA." In total, 77 and 78 people in the GG group were assigned to magnesium and placebo respectively, while 47 and 48 people in the GA/AA group were assigned to magnesium and placebo respectively. Most participants completed the 12-week study. The trial was measuring changes in the levels of six specific proteins in the lining of the large bowel — TRPM7, COX2, TUNEL, BAX, pMLKL, and Ki67 — which are associated with how bowel cells grow, die, and behave. Levels were measured before and after the 12-week treatment period. The reported data shows the changes in each protein were expressed as a mathematical score (the difference in a log-transformed value from the start to the end of the study, where a positive number means the level went up and a negative number means it went down). For TRPM7, the GG magnesium group showed a small increase (+0.03) compared to GG placebo (+0.08), while the GA/AA magnesium group showed a small decrease (−0.09) similar to GA/AA placebo (−0.11). For COX2, changes were +0.10 (GG magnesium), +0.08 (GG placebo), +0.11 (GA/AA magnesium), and −0.29 (GA/AA placebo). For TUNEL, the figures were +0.24, +0.14, −0.09, and −0.09 across the four groups in the same order. For BAX, the reported changes were −0.03, −0.30, −0.18, and −0.19. For pMLKL, they were +0.11, +0.05, +0.02, and −0.16. For Ki67, the reported figures were −0.11, +0.11, −0.03, and −0.10. No secondary outcome data was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT05983367 · results posted 20 February 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total — 38 in each group. All participants had a type of cancer being treated with a chemotherapy-and-antibody combination called FOLFIRI plus bevacizumab. One group also received an investigational drug called ompenaclid, while the other received a placebo (a dummy treatment) alongside the same chemotherapy. The trial was primarily measuring the proportion of participants whose tumours shrank or disappeared, and it also tracked how long people went without their disease getting worse, how long they survived, and how many experienced unwanted side effects. The reported data shows that, for the main measure (tumour shrinkage or disappearance), 8 out of 38 participants responded in the ompenaclid group and 8 out of 38 responded in the placebo group. Breaking that down further, 2 participants in the ompenaclid group had a complete disappearance of target tumour areas compared with 4 in the placebo group, while 6 had a partial shrinkage in the ompenaclid group compared with 4 in the placebo group. For the secondary measures, the reported median time before disease progressed was 8.8 months in the ompenaclid group and 8.1 months in the placebo group. The proportion of participants still alive at 9 months was reported as 88.5% in the ompenaclid group and 69.0% in the placebo group; at 12 months, those figures were 88.5% and 61.3% respectively. The median duration of response was not reached in either group by the time results were recorded. Disease was reported as controlled (shrinkage or stability) in 36 out of 38 participants in the ompenaclid group and 30 out of 38 in the placebo group. Regarding unwanted events, 37 out of 38 participants in the ompenaclid group and all 38 in the placebo group were reported to have experienced at least one treatment-related adverse event, though the severity of those events was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03377361 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03377361) enrolled a total of 299 participants across ten different groups. The trial was set up in multiple parts and looked at an investigational treatment across different dosing groups and combinations. The earlier parts of the trial (Parts 1 and 1A) focused on tracking certain types of medical events — including any new or worsening health issues, abnormal blood test results related to the thyroid and liver, and specific events considered "dose-limiting" (meaning reactions serious enough that they might require changing the dose). The later parts (Parts 1B and 2) looked at how many participants had a measurable reduction in their condition, known as the "overall response rate." The reported data shows that in the earlier dosing groups (Parts 1 and 1A), dose-limiting events were recorded in 1 participant out of 6 in one group, and 1 out of 7 in another group; all other groups in this phase reported zero such events. Abnormal thyroid test results were reported in small numbers across groups, ranging from 0 to 3 participants per group. Abnormal liver test results ranged from 0 to 2 participants per group. For the response rate outcomes — meaning the proportion of participants whose condition showed a confirmed measurable improvement — the reported data shows 9.8% in the Part 1B group, and 1.6% in each of the two Part 2 treatment groups. As a secondary measure, the reported response rates in Parts 1 and 1A ranged from 0% in most groups up to 28.6% in one group (7 participants) and 33.3% in another (3 participants). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02060188 · results posted 6 November 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people across nine treatment groups, all receiving different combinations of immunotherapy drugs (nivolumab, ipilimumab, and others) for colorectal cancer. The trial was measuring what is called the "objective response rate" — that is, the percentage of participants whose tumours shrank by a meaningful amount or disappeared entirely, based on standardised imaging measurements. It is noted that zero participants were recorded as having "completed" the study in the formal sense, meaning all participants fell into the "not completed" category, though no further explanation for this is provided in the reported data. The reported data shows that response rates varied widely depending on which treatment group participants were in. For the primary measure (assessed by the treating doctors), the reported rates ranged from 0% up to 71.1%. Specifically: Cohort 1 (nivolumab alone) reported 40.5%; Cohort 2 (nivolumab + ipilimumab) reported 66.4%; Cohort 3 (a different nivolumab + ipilimumab schedule) reported 71.1%; Cohort 4 (nivolumab + ipilimumab + cobimetinib) reported 3.3%; Cohort 5 (nivolumab + BMS-986016) reported 50.0%; and Cohort 6 (nivolumab + daratumumab) reported 0%. Three sub-groups reported 0%, 0%, and 10.0% respectively. A second, independent review of the same scans (the secondary outcome) produced broadly similar but not identical figures across the six cohorts for which that data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04008030 · results posted 22 September 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04008030) enrolled 839 people across three groups: 353 received nivolumab alone (Arm A), 354 received nivolumab combined with ipilimumab (Arm B), and 132 received standard chemotherapy chosen by their doctor (Arm C). The trial was measuring "progression-free survival" — that is, how long participants went without their disease getting worse or dying — comparing the immunotherapy options against each other and against chemotherapy, in people whose cancer had a specific genetic feature called MSI-H or dMMR. The reported data shows the following progression-free survival figures, expressed as median months (meaning the point at which half the group had experienced disease progression or death, and half had not). For the primary comparison between Arm A (nivolumab alone) and Arm B (nivolumab + ipilimumab) in participants with centrally confirmed MSI-H/dMMR tumours, Arm A recorded 39.26 months, while the median for Arm B was listed as "NA" — meaning it had not been reached at the time the data was collected and was therefore not reported as a number. For the primary comparison between Arm B and chemotherapy (Arm C) in first-line participants, the chemotherapy group recorded 5.85 months, while again Arm B's median was not reached and reported as "NA." In a broader secondary analysis covering all randomly assigned participants, Arm A recorded 18.43 months and Arm B recorded 54.08 months. In another secondary analysis limited to first-line participants, Arm A recorded 44.85 months, Arm C recorded 6.21 months, and Arm B's median was again not reached. Some secondary outcome measures had no data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04827732 · results posted 11 September 2025

  According to the results reported on ClinicalTrials.gov, this trial tested a type of targeted radiation therapy called proton therapy (specifically, hypofractionated pencil-beam scanning IMPT) in people whose cancer had returned to a previously treated area of the pelvis. The treatment was delivered in 5 sessions and tested at different dose levels (labelled Dose Level -1, 1, 2, and 3) to find the highest dose that could be given without causing too many serious side effects. A total of 15 people took part across all dose levels — 1 at Dose Level -1, 7 at Dose Level 1, 3 at Dose Level 2, and 4 at Dose Level 3. Most participants completed the study, with 2 not finishing (one each from Dose Levels 1 and 3). The reported data shows that the primary goal — finding the maximum tolerated dose (that is, the highest dose linked to an acceptable rate of serious side effects, defined in this trial as a 35% chance of a dose-limiting reaction) — was reported as 40 Gray delivered in 5 treatment sessions. For the secondary outcomes, the reported data shows that no participants across any dose level achieved a "clinical complete response" (meaning no measurable disappearance of tumour was recorded by examination and scans). The time until the cancer progressed locally or regionally (called "freedom from locoregional progression") was reported as a median of 7.53 months for Dose Level 1, 9.53 months for Dose Level 2, and 4.37 months for Dose Level 3. Median overall survival — the point at which at least half of participants in a group had died — was reported as 9.53 months for Dose Level 2; for Dose Levels 1 and 3 this figure was listed as "NA," meaning it was not reached or not reported with available data. Median progression-free survival (time before disease worsened or death) was 2.04 months for Dose Level 1, 9.53 months for Dose Level 2, and 4.37 months for Dose Level 3. Quality-of-life scores, measured using a standard 30-question survey, showed small changes from before to after treatment that varied across dose levels and survey categories; the data for Dose Level -1 was not reported for most quality-of-life measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT05330429 · results posted 1 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05330429) involved 77 people in total across three groups. Ten participants joined an initial "safety run-in" group receiving a combination of three treatments: magrolimab, bevacizumab, and FOLFIRI (a chemotherapy regimen). After that, 44 people were randomly assigned to receive the same three-drug combination, while 23 people were randomly assigned to receive bevacizumab and FOLFIRI without magrolimab. The trial was measuring, among other things, how long participants went without their disease getting worse (called "progression-free survival"), as well as how many people's tumours shrank, and various safety-related observations in the run-in group. No participants were recorded as having formally "completed" the study, meaning all participants had left the study before its planned end — the data does not explain the reasons for this in the structured results. The reported data shows that in the safety run-in group, none of the 10 participants experienced what the trial defined as a "dose-limiting toxicity" (a serious side effect severe enough to limit the dose). However, 100% of participants in that group experienced at least one adverse event (an untoward medical occurrence during the study period), and 100% had at least one laboratory test result that worsened by at least one level of severity, with 90% recorded under a second laboratory abnormality category. For the randomly assigned groups, the reported median progression-free survival — that is, the midpoint time before disease worsened or death occurred — was 6.2 months for the magrolimab combination group and 6.7 months for the group without magrolimab. Regarding tumour shrinkage (called "objective response rate"), 13.6% of participants in the magrolimab combination group had their tumours shrink to a meaningful degree, compared with 0% in the comparison group. The duration of how long those responses lasted was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04625803 · results posted 17 June 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04625803) enrolled 64 participants, all of whom received a combination of chemotherapy, a PD-1 inhibitor (a type of immunotherapy drug), and apatinib (a targeted therapy drug). The trial was focused on people with a specific type of rectal cancer classified as MSS/pMMR — meaning the cancer cells have a particular molecular characteristic. The main thing the trial set out to measure was the "tumour regression rate," which refers to how much the tumour had shrunk or changed in the tissue examined after treatment, rated on a grading scale of 2 to 4. Of the 64 people who started, 12 were recorded as having completed the study, and 52 did not complete it. The reported data shows that 7 participants fell into the tumour regression grade 2–4 category, which was the primary measurement the trial was tracking. No percentage breakdown was provided beyond this count of 7 participants. For all of the secondary outcomes — including pathological complete response (whether the cancer completely disappeared from tissue samples), R0 resection rate (whether surgeons were able to remove all visible cancer), two-year disease-free survival, overall survival, and event-free survival — no numerical results were reported in the data submitted to ClinicalTrials.gov. Because the secondary outcome data was not reported, a full picture of what was measured across all goals of the trial is not available from the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04472429 · results posted 23 May 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04472429) enrolled 308 participants across two groups during its main randomised period: 154 people received retifanlimab (a type of immunotherapy drug) combined with chemotherapy, and 154 people received a placebo (an inactive substance) combined with chemotherapy. A third group of 69 participants later entered a separate open-label phase and received retifanlimab on its own — these were participants who had been in the placebo plus chemotherapy group. The trial was primarily measuring "progression-free survival," which means how long participants went before their disease worsened or they passed away, whichever came first. The reported data shows that, for the primary outcome of progression-free survival, the retifanlimab plus chemotherapy group had a reported median of 9.3 months, compared with 7.4 months in the placebo plus chemotherapy group. (A "median" here means the midpoint figure — half the people in that group reached this time point or beyond before their disease progressed or they died.) For the adverse events outcome (unintended or unwanted medical occurrences that happened during treatment), the reported data shows that all 154 participants in the retifanlimab plus chemotherapy group and 152 out of 152 participants in the placebo plus chemotherapy group experienced at least one such event during the randomised period. For the remaining secondary outcomes — including overall survival, objective response rate (how many people's disease shrank or disappeared), duration of response, and disease control rate — the data was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00574353 · results posted 9 May 2025

  According to the results reported on ClinicalTrials.gov, 23 people took part in this trial, and all 23 completed it. The trial was looking at whether a special type of scan — called an F-FMISO PET scan — could be used as a non-invasive way to detect low oxygen levels (known as hypoxia) inside colorectal cancer tumours. The scan used a radioactive tracer called fluoromisonidazole (FMISO) to try to measure how the tumour was taking up and holding onto the tracer over time. The reported data shows that, of the 23 participants, 18 were successfully scanned using the F-FMISO PET imaging, while 5 were not successfully scanned. The scan results were used to calculate how quickly the tracer was absorbed by the tumour and how strongly it bound there, which researchers used to assess whether the approach could feasibly detect low-oxygen areas in the tumour. For a secondary measure, the reported data shows that blood samples were collected from participants to track how the tracer moved through the body over time. According to the results reported on ClinicalTrials.gov, 10 participants had blood samples collected at one point, and 13 had blood samples collected at another — though further detail on what those blood results showed was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT05002608 · results posted 21 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05002608) looked at a Health Insurance Navigation Program. A total of 36 people took part — 17 in the "Navigation Intervention" group (who received the navigation program) and 19 in the "Enhanced Usual Care" group (who received a comparison level of support). The trial was measuring three main things: how acceptable participants found the navigation program, whether people's understanding of health insurance terms changed over five months, and how feasible the program was to deliver (meaning whether participants could complete all five sessions). The reported data shows that, on a scale of 1 to 10 (where 10 means most helpful), participants in the Navigation Intervention group rated the program's quality at an average of 8.8. For health insurance literacy — measured on a scale where a higher score means a *greater* understanding of terms like premiums, deductibles, and co-payments — the Navigation Intervention group's average score changed by 5.6 points from the start of the trial to the five-month follow-up, compared to a change of 1.1 points in the Enhanced Usual Care group. Regarding feasibility, the reported data shows that 15 out of 17 participants in the Navigation Intervention group completed all five program sessions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02965703 · results posted 4 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02965703) enrolled 70 people across three groups: 29 in the aspirin-only group, 33 in the aspirin-plus-placebo group, and 8 in the placebo-only group. Not everyone finished the trial — 19, 28, and 6 people respectively completed it in each group. The trial was looking at changes in biological markers measured from bowel tissue samples, specifically the balance between two processes in cells: how quickly cells multiply (called proliferation) and how quickly they break down or die off (called apoptosis or necroptosis). These were measured using laboratory staining techniques on rectal tissue biopsies. The reported data shows the following changes in the ratio of cell multiplication to cell breakdown (where a lower number means the balance shifted more toward cell breakdown relative to multiplication). For the main outcome measured using the Ki67 and BAX markers, the aspirin-only group showed a change of −0.11, the aspirin-plus-placebo group showed no change (0.00), and the placebo-only group showed a change of −0.23. For a secondary measure using Ki67 and a different breakdown marker (TUNEL), the reported changes were −1.27, +0.63, and −0.70 respectively. For a third measure involving a cell death process called necroptosis (using a marker called MLKL), the reported changes were +0.58, −0.02, and −0.32 across the three groups. Separately, a stool test for hidden blood — used to monitor for potential gut-related concerns — came back positive for 1 person in the aspirin-only group, 2 people in the aspirin-plus-placebo group, and no one in the placebo-only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03516942 · results posted 17 February 2025

  According to the results reported on ClinicalTrials.gov, this observational study (NCT03516942) enrolled 565 people who had been diagnosed with colon or rectal cancer and were being treated with the aim of curing the disease. Participants were asked to complete questionnaires about their financial situation and ability to work — at the start of the study (within 60 days of diagnosis), and then again at 3, 6, and 12 months. A total of 450 people submitted the initial baseline survey, and numbers fell over time, with 207 people completing both the baseline and the 12-month survey. The reported data shows that the main thing being measured was financial hardship, using a tool called the COST score (ranging from 0 to 44, where a higher number means better financial wellbeing). At the start of the study, the average COST score was reported as 23.5. At the 6-month point, the average score was reported as 28.6, suggesting the reported figure was higher (better) at that later time point. It should be noted that the 12-month comparison data — which was the study's primary goal — does not appear to have been separately reported in the submitted results. For work and daily activity, the reported data shows that the percentage of daily activities participants said were affected by their illness started at around 51.8% at baseline, and the figures reported at 6 months, 12 months, and 24 months were 36.6%, 17.8%, and 19.1% respectively. Two secondary outcomes — access to financial support services and long-term follow-up adherence — had no numerical results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01652196 · results posted 5 February 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 56 participants, all of whom completed the study. Every participant received aflibercept combined with chemotherapy. The trial was primarily measuring how many participants were still alive and had not seen their disease get worse at the 15-month mark. It also tracked a number of secondary measures, including how many participants' tumours shrank or disappeared, how many were able to have surgery, how long participants went without their disease getting worse, and how long participants lived overall. The reported data shows that at 15 months, approximately 48 in every 100 participants (a proportion of 0.482) were still alive and had not experienced disease progression. For the secondary measures, around 45 in every 100 participants (proportion of 0.446) had their tumour shrink or disappear based on standard imaging assessments. Approximately 5 in every 100 participants went on to have surgery. The reported data shows that, on average, participants went around 7.8 months before their disease progressed, and the average overall survival was reported as approximately 19.7 months. Regarding side effects rated as severe (grade 3 or above — meaning serious enough to require medical attention), the reported data shows rates of 33.9%, 25%, 12.5%, and 10.7% across different categories of adverse events, though the specific side effect categories for each of these figures were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03298945 · results posted 22 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03298945) involved 2,239 people in total — 1,139 who were assigned to use a bowel preparation product called GoLytely, and 1,100 who were assigned to use a MiraLax-Gatorade preparation. All participants who started the trial were recorded as completing it. The trial was measuring two main things: how many people actually turned up for their scheduled colonoscopy and had their bowel preparation rated as "adequate" by the doctor performing the procedure, and how many people had at least one polyp (called an adenoma — a small growth in the bowel) detected during their colonoscopy. The reported data shows that, for the first main measure (showing up and having adequate bowel preparation), 591 out of 1,139 participants in the GoLytely group and 600 out of 1,100 participants in the MiraLax-Gatorade group met this combined result. For the second main measure (polyp detection), 383 participants in the GoLytely group and 364 in the MiraLax-Gatorade group had at least one polyp found. The reported data also shows that 358 people in the GoLytely group and 330 people in the MiraLax-Gatorade group either cancelled their appointment or did not show up. Two other planned measures — the quality of bowel preparation rated on its own, and an outcome related to low sodium levels in the blood — were listed in the trial records but no numerical results were reported for these. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03095703 · results posted 24 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03095703) enrolled 4 participants, all of whom received a drug called sirolimus. Three participants completed the trial, while one did not finish. The trial was measuring changes in the size and number of intestinal polyps (small growths inside the bowel) over 6 months of treatment, as well as recording any unwanted side effects that occurred during that time. The reported data shows that for the primary outcome looking at changes in the size of marked polyps, three separate measurements were recorded for the group: 16, 4, and 0 (in units described as "size of marked polyps" — the data does not provide further detail on what these numbers specifically represent). For treatment-related unwanted side effects, the reported median (middle value) number of events per participant was 10. For the secondary outcomes, the reported median difference in the number of intestinal polyps between the start and after 6 months was 25.75 polyps. When reviewers assessed the overall polyp burden (the general load of polyps across the bowel), the reported data shows that 0 participants were rated "much better," 3 were rated "better," 1 was rated "the same," 0 were rated "worse," and 0 were rated "much worse." It is worth noting that with only 4 participants enrolled, this was a very small study, and the data as submitted to ClinicalTrials.gov does not include full explanatory context for all of the numbers listed above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04456699 · results posted 2 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04456699) enrolled 335 people across three groups: 111 received a combination of olaparib and bevacizumab, 115 received olaparib alone, and 109 received bevacizumab combined with chemotherapy. The trial was primarily measuring how long participants went without their cancer growing or spreading — known as "progression-free survival" — as judged by an independent review team who did not know which treatment each person was receiving. The reported data shows that the median time before the cancer progressed (or death occurred) was 3.7 months in the olaparib-plus-bevacizumab group, 3.6 months in the olaparib-alone group, and 5.5 months in the bevacizumab-plus-chemotherapy group. For overall survival (how long participants lived from the start of the trial), the reported figures were 21.2 months, 21.6 months, and 19.9 months respectively. The proportion of participants whose tumours shrank meaningfully — called the "objective response rate" — was reported as 4.8% in the olaparib-plus-bevacizumab group, 1.9% in the olaparib group, and 4.8% in the bevacizumab-plus-chemotherapy group. The duration of that tumour response was not reported for any of the three groups. The reported data also shows that unintended medical events (called "adverse events") during the trial were recorded in 101 of 111 participants in the olaparib-plus-bevacizumab group, 91 of 113 in the olaparib group, and 96 of 108 in the bevacizumab-plus-chemotherapy group. A smaller number — 6, 4, and 7 participants in each group respectively — stopped their treatment early because of such an event. Noting that zero participants were recorded as having formally "completed" the study, the data does not explain the reasons for this, and no further detail was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  Read the full trial page

• NCT02943265 · results posted 6 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02943265), called Project CONNECT, involved three groups of participants. The main group — people with complex cancer histories who received care coordination through the Project CONNECT program — started with 648 participants, with 634 completing the study. A second group of 2,674 people was included as a historical (retrospective) comparison group of cancer survivors, of whom 2,092 were considered eligible after review. A third group of 1,000 people without cancer was also included for comparison purposes. The trial was measuring two main things: how well complex cancer survivors met recommended guidelines for managing ongoing health conditions and cancer follow-up care, and how participants in the Project CONNECT group felt about the coordination of their care. The reported data shows that for the first primary outcome — whether cancer survivors were meeting quality-of-care guidelines — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the second primary outcome, participant perceptions of care coordination were measured using a survey scored on a scale of 8 to 24, where a lower number means better perceived coordination. The reported data shows that Project CONNECT participants scored 11.4 at the start of the study, 11.2 at six months, and 10.8 at twelve months. Only the Project CONNECT group completed this survey, so no comparison scores from the other groups were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04744831 · results posted 2 January 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04744831) enrolled 122 adults with a specific type of advanced bowel cancer (metastatic colorectal cancer) whose tumours produced high levels of a protein called HER2. Participants were split into two groups based on the dose of the study drug, T-DXd (also called trastuzumab deruxtecan): 82 people received the lower dose (5.4 mg/kg every three weeks) and 40 received the higher dose (6.4 mg/kg every three weeks). The trial's main goal was to measure how many participants' tumours shrank or disappeared — known as the objective response rate — as judged by an independent review panel who did not know which dose each person had received. The reported data shows that, based on that independent review, 37.8% of participants in the lower-dose group and 27.5% in the higher-dose group had their tumours shrink or disappear by a meaningful amount. When the treating doctors made their own assessments, the reported figures were 31.7% and 30.0% respectively. The reported data also shows that the median time participants who responded maintained that response (called duration of response) was around 5.5 to 6.9 months across both groups and both review methods. In terms of disease control — meaning tumours that either shrank or remained stable for at least six weeks — the reported rate was approximately 86–89% in the lower-dose group and 85% in the higher-dose group. The median time before the cancer progressed or death occurred (progression-free survival) was reported as approximately 5.8 months in the lower-dose group and 5.5–5.7 months in the higher-dose group. The data notes that zero participants in either group were recorded as having "completed" the study, though the reasons for this were not detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04068610 · results posted 15 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04068610) enrolled 59 people across three groups. Seven participants took part in Part 1, which tested a four-drug combination (FOLFOX, Bevacizumab, Durvalumab, and Oleclumab) and focused mainly on monitoring safety signals — things like serious unwanted medical events, significant changes in blood test results, and abnormal vital signs. The remaining 52 participants were split evenly into two groups in Part 2 (26 each): one group received FOLFOX plus Bevacizumab, and the other received the same four-drug combination from Part 1. Part 2 focused on measuring how many participants' tumours shrank or disappeared. It is worth noting that none of the participants were recorded as having "completed" the study in the formal sense, though the data was still reported. The reported data shows that in Part 1, all 7 participants experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened after starting the study drugs), and 1 of the 7 experienced a serious adverse event. No participants in Part 1 were recorded as having a dose-limiting toxicity (a side effect severe enough to limit how much of the drug could be given). Various numbers of participants — ranging from 1 to 4 out of 7, depending on which specific lab test was looked at — showed notable changes in blood test results. Abnormal vital signs reported as adverse events were recorded in small numbers across different measurements (2, 1, and 3 participants respectively for the different vital sign categories). The reported data shows that in Part 2, the proportion of participants whose tumours shrank or disappeared (called the "objective response rate") was 46.2% in the FOLFOX plus Bevacizumab group and 61.5% in the four-drug combination group. For Part 1, the reported objective response rate was 71.4% (5 of the 7 participants). These figures describe what was observed and recorded in this specific trial — they do not account for all factors that may influence such results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01133990 · results posted 7 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT01133990) was designed in two stages. The first stage (Phase 1b) aimed to find a suitable dose of a medicine called E7820 when combined with a chemotherapy regimen called FOLFIRI, by looking at side effects and other safety-related measurements. The second stage (Phase 2) was intended to compare three groups — FOLFIRI alone, FOLFIRI combined with a medicine called Bevacizumab, and FOLFIRI combined with E7820 — measuring how long participants went without their disease getting worse. Only 5 people participated in the first stage (all receiving E7820 at 40 mg per day plus FOLFIRI), and the reported data shows that no participants were recorded as starting the second stage at all. The reported data from the first stage shows that all 5 participants experienced at least one treatment-emergent adverse event (that is, a medical event that occurred after starting the study drug). Of those 5 participants, 2 were reported as experiencing dose-limiting toxicities — meaning side effects serious enough, within the first 28 days, that investigators considered them relevant to deciding on the dose. Two participants had clinically significant changes noted during physical examinations, and 1 had a clinically significant change recorded on a heart tracing (ECG). Regarding participants' general ability to function day-to-day (scored on a 0–5 scale), 1 participant scored 0 (fully active), 2 scored 1 (some physical restrictions), and 2 scored 2 (able to care for themselves but unable to work). The reported data shows that no results were recorded for the key Phase 2 outcome — the length of time participants went without their disease progressing — because no participants appear to have entered that stage of the trial. The reasons for this are not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03750786 · results posted 26 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03750786) enrolled 490 people in total, split evenly into two groups of 245 — referred to here as Group A and Group B. The trial was measuring how tumours responded to treatment, how long it took before the disease worsened, and how long any response to treatment lasted. The reported data shows that none of the participants were recorded as having "completed" the study in the formal sense, with all 490 listed as "not completed" — though this may reflect how the trial's completion was defined and recorded rather than dropouts. The reported data shows that for the main measure — called the Overall Response Rate, which tracks the best tumour response seen during treatment — the breakdown of participant responses across both groups included small numbers recorded as having a complete response (2 in Group A, 5 in Group B), with larger numbers showing a partial response (116 in each group), stable disease (106 in Group A, 86 in Group B), disease progression (7 in Group A, 11 in Group B), and other categories accounting for the remaining participants. For the secondary measures, the reported data shows that the time before disease worsened (Progression Free Survival) was 12.8 months for Group A and 11.6 months for Group B. The length of time a response lasted (Duration of Response) was reported as 12.2 months for Group A and 12.9 months for Group B. These figures are counts and timeframes as recorded in the trial data — they describe what was observed in these specific participants under study conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04322539 · results posted 14 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04322539) enrolled 691 people with advanced colorectal cancer who had already tried other treatments. Participants were randomly assigned to receive either fruquintinib (a tablet medicine) plus best supportive care (461 people) or a placebo (a dummy pill) plus best supportive care (230 people). The trial was primarily measuring how long participants lived overall, and also tracked several secondary measures including how long it took for the cancer to progress on scans, how many participants saw their cancer shrink, and how many experienced adverse (unwanted) health events during the study. No participants were recorded as having "completed" the study, which is common in trials like this where follow-up continues until a predefined point. The reported data shows that the median overall survival — that is, the midpoint time at which half the participants in each group had died — was 7.4 months in the fruquintinib group compared with 4.8 months in the placebo group. For progression-free survival (the time until scans showed the cancer had grown or the person died), the reported median was 3.7 months in the fruquintinib group and 1.8 months in the placebo group. When looking at tumour shrinkage, 1.5% of participants in the fruquintinib group had their cancer shrink by a meaningful amount, compared with 0% in the placebo group. A broader measure called disease control rate — which also counts people whose cancer stayed stable for at least 7 weeks — was reported as 55.5% in the fruquintinib group and 16.1% in the placebo group. Among those in the fruquintinib group whose cancer did shrink, the reported median time that the response lasted was 10.7 months; this figure was not reported for the placebo group (likely because too few participants in that group had a response to calculate it). The reported data also shows that 451 out of 456 people in the fruquintinib group experienced at least one treatment-emergent adverse event (an unwanted health event that occurred during or shortly after treatment), compared with 214 out of 230 in the placebo group. Serious adverse events were reported in 173 people in the fruquintinib group and 88 people in the placebo group. These numbers describe what was recorded and counted — they do not, on their own, tell us what caused these events or how severe they were for each individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03735407 · results posted 13 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03735407) involved 40 participants who all completed the study — none dropped out. The trial was testing a device called the C-Scan system (also referred to as the Check-Cap system), which is a capsule-based procedure intended as an alternative to colonoscopy for examining the bowel. The trial measured three things: whether any serious harmful events related to the device or procedure occurred, how well participants stuck to the study requirements, and how satisfied participants were with the experience compared to colonoscopy. The reported data shows that zero out of 40 participants experienced a serious harmful event that was judged to be related to the device or procedure. For the compliance measure — that is, how well participants followed the study requirements throughout the trial — the reported data shows that all 40 participants were counted in this outcome, though a breakdown of the actual non-compliance rate percentage was not reported in the submitted data. Regarding satisfaction, participants filled out a questionnaire rating their experience on a scale of 1 (low satisfaction) to 5 (high satisfaction). The reported average satisfaction score for the C-Scan procedure was 3.42. The study had set a target of an average score above 3.5 to indicate high satisfaction, and the reported result fell just below that mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01011478 · results posted 16 August 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 406 people — 204 in a placebo group and 202 in a rosuvastatin (a cholesterol-lowering medication) group. The trial was looking at people who had previously had colon cancer, and it was measuring whether rosuvastatin had any effect on the development of new bowel polyps (small growths in the bowel that can sometimes become cancerous), new colorectal cancers, or a return of their original colon cancer. Most participants completed the study — 192 in the placebo group and 195 in the rosuvastatin group. The reported data shows that for the main outcome — the proportion of participants who developed at least one adenomatous polyp (a specific type of bowel polyp), a new colorectal cancer, or a recurrence of their colon cancer — 25.0% of people in the placebo group and 28.2% in the rosuvastatin group experienced one of these events. For the secondary outcomes, the reported data shows the average size of the largest polyp found was 0.4 centimetres in both groups. In terms of disease-free survival (meaning no cancer recurrence, new primary cancer, or death from any cause), 17 people in the placebo group and 21 in the rosuvastatin group experienced one of those events. Deaths from any cause were recorded for 1 person in the placebo group and 4 in the rosuvastatin group. Colon cancer returning was recorded for 12 people in the placebo group and 14 in the rosuvastatin group. A new, unrelated cancer (not colorectal) was recorded for 4 people in the placebo group and 7 in the rosuvastatin group. It is worth noting that this data represents raw numbers and proportions as submitted by the trial sponsor, and no further detail about the timeframes or statistical analysis of these figures was included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02728804 · results posted 26 January 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 380 people who were receiving cancer treatment. All participants were asked to fill in questionnaires tracking the financial impact of their treatment over 12 months. Of the 380 who started, 368 completed the first questionnaire, and 269 finished the full study. The trial was not testing a medicine or procedure — instead, it was measuring how often cancer treatment led to serious financial hardship, and whether that differed depending on a person's age, race, marital status, employment, or income. The reported data shows that the main thing being measured was "major financial hardship," which the researchers defined as any of the following happening during treatment: taking on debt of any amount, selling or refinancing a home, a drop in household income of 20% or more, or borrowing money from family or friends. The reported cumulative incidence (an estimate of how many people experienced these things over the 12 months) included several figures across different hardship types, with an overall figure of approximately 71.3% reported for one measure of major financial hardship, and other related figures of 57.6%, 26.6%, 26.0%, 3.4%, and 2.6% — though the trial's submitted data does not clearly label which specific hardship type each of these numbers corresponds to. The reported data also shows figures broken down by participant characteristics. For age, the reported rates were around 73.7% for those under 65 and 68.1% for those 65 and older. By race, the figures were approximately 70.3% for white participants and 73.9% for non-white participants. By marital status, 69.0% for those not married and 72.2% for married participants. By employment before diagnosis, 62.9% for those who were unemployed and 76.2% for those in any employment. By income, figures ranged from approximately 64.9% to 72.9% across different income brackets. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01079780 · results posted 10 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01079780) enrolled 136 participants across three treatment groups: Arm A (70 people), Arm B (16 people), and Arm C (50 people). The trial was measuring how different chemotherapy combinations affected people with cancer, looking mainly at how long participants lived without their disease getting worse (called "progression-free survival"). It also tracked whether tumours shrank, how long participants survived overall, and how many experienced serious side effects linked to treatment. The reported data shows that for the main measure — time without disease worsening — participants in Arm A went a median of about 6 months, Arm B about 7 months, and Arm C about 9.2 months before their disease progressed or they passed away. For overall survival (time from the start of the trial until death), the reported figures were approximately 19.3 months for Arm A, 15.0 months for Arm B, and 19.2 months for Arm C. When it came to tumour shrinkage (either complete or partial), the reported proportions were 23% of participants in Arm A, 44% in Arm B, and 36% in Arm C. Regarding serious treatment-related side effects (graded as severe or worse on a standard medical scale), the reported data shows these occurred in 49% of Arm A participants, 81% of Arm B participants, and 56% of Arm C participants. It is worth noting that the number of participants available for the main tumour response analysis differed from those who started — 44 in Arm A, none counted in Arm B, and 45 in Arm C — and no participants were recorded as formally "completing" the study under the trial's definitions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03542877 · results posted 2 June 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants, all of whom received oral cabozantinib. Of those 44, 23 completed the study and 21 did not. The trial was primarily measuring how many participants showed no sign of their disease getting worse at the 12-week mark — a concept called "progression-free survival." It also looked at whether certain genetic features of participants' tumours (specifically mutations in genes called RAS and PIK3CA) were linked to different results on that same measure. The reported data shows that out of the 44 participants, 18 were recorded as progression-free (disease not worsening) at 12 weeks. When broken down by genetic profile, 7 of those 18 had a RAS gene mutation, while 11 did not. Similarly, 3 had a PIK3CA gene mutation and 11 did not (noting these subgroups may overlap). The reported data also shows that, overall, the median time participants went without their disease progressing was 13 weeks — meaning half of participants reached that point before the 13-week mark and half after. When split by genetic profile, the reported median progression-free time was 12 weeks for those with a RAS mutation compared with 21 weeks for those without, and 26 weeks for those with a PIK3CA mutation compared with 20 weeks for those without. These figures are based on a relatively small group of participants, and the data as submitted does not include further statistical detail beyond the numbers described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02384850 · results posted 8 April 2022

  According to the results reported on ClinicalTrials.gov, this trial involved 10 people with metastatic colorectal cancer (cancer that has spread beyond the bowel). Participants were split into two groups: 4 people received a higher dose of a drug called selinexor (40 mg) combined with a standard chemotherapy regimen called mFOLFOX6, and 6 people received a lower dose of selinexor (20 mg) with the same chemotherapy. The main thing the trial was trying to measure was the highest dose of selinexor that could be given alongside the chemotherapy without causing unacceptable side effects — this is called the "maximum tolerated dose." Of the 10 participants who started, 6 completed the study (2 in the higher-dose group and 4 in the lower-dose group). The reported data shows that in the higher-dose group (40 mg), 2 out of 4 participants experienced what the trial defined as a "dose limiting toxicity" — meaning a serious enough side effect or other problem that limited how the dose could be used. In the lower-dose group (20 mg), 2 out of 6 participants also experienced a dose limiting toxicity. For the secondary measurements, the reported data shows that 1 participant in the lower-dose group had a measurable reduction in tumour size meeting the trial's response criteria, while none in the higher-dose group did. Progression-free survival (how long participants went without their cancer getting worse) was not reported for either group. Regarding overall survival (how many participants were still alive at the end of the study), the reported data shows 0 out of 4 in the higher-dose group and 2 out of 6 in the lower-dose group. All 10 participants across both groups were reported to have experienced at least one adverse event (an unwanted or unexpected medical occurrence) during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03750461 · results posted 10 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03750461) enrolled 20 people in the intervention group and compared their outcomes against a separate group of 92 historical controls — meaning people whose records were reviewed from past treatment rather than people enrolled in the current study. The trial was looking at whether a mesh implant placed during ileostomy closure (a bowel surgery) affected wound problems and hernia formation at the closure site, as well as bowel function and quality of life. The reported data shows that, among the 20 people in the intervention group, zero participants experienced any wound occurrence — such as infection, wound opening, or fluid collection — within 30 days. Among the 92 historical controls, the reported data shows 5 participants had one type of wound occurrence and 4 had another type, though the data as submitted lists some comparison figures as zero, making the full breakdown across all categories difficult to interpret completely. For hernia formation (assessed at 30 days and at six-monthly intervals up to two years), the reported data shows zero participants in the intervention group developed a hernia at the ileostomy site. On the bowel function questionnaire (scored 0–100, where higher means worse function), the reported average score was 12. On the quality-of-life questionnaire (scored 0–40, where higher means better quality of life), the reported average score was 33. It is worth noting that one participant did not complete the study, and secondary outcome data was only collected for the intervention group — no secondary outcome data was reported for the historical controls group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00321100 · results posted 12 January 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total — 12 in one group and 11 in another. All participants completed the study. The trial was looking at two different combinations of cancer medicines given to people with advanced colorectal (bowel) cancer. One group received cetuximab, oxaliplatin, capecitabine, and bevacizumab together, while the other group received the same medicines but without bevacizumab. The trial was measuring how many participants' tumours shrank or disappeared, how long it took for the disease to get worse, and how long participants lived overall. The reported data shows that, for the main measure — whether tumours responded to treatment — 4 out of 12 people in the four-drug group had a measurable response (either full or partial tumour shrinkage), compared with 8 out of 11 people in the three-drug group. For the secondary measures, the reported data shows that the average time before the disease progressed was 8.7 months in the four-drug group and 14.4 months in the three-drug group. The reported overall survival figures were 18 months on average for the four-drug group and 42.5 months for the three-drug group. No additional breakdown of these figures was reported in the submitted data. It is worth noting that only 23 people took part in this trial in total, which is a very small number, and this limits how broadly any of these figures can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00291486 · results posted 11 January 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total, spread across five groups (called cohorts) of 3–6 participants each. The trial was an early-phase study looking at a combination of a radioactive antibody treatment (called ¹³¹I-huA33) and a chemotherapy tablet (capecitabine) in people with cancer. Because it was an early-phase trial, the main thing being measured was whether certain serious side effects — called dose-limiting toxicities — occurred at different dose levels of the radioactive antibody. Researchers also tracked how the treatment moved through the body, how much radiation reached tumours and normal organs, and whether tumours showed any change in size. Not all participants finished the study: 12 of the 19 completed it, and 7 did not. The reported data shows that dose-limiting toxicities were recorded in 2 out of 6 participants in Cohort 2, and in zero participants across the other four cohorts. For tumour size changes (assessed using a standard measurement system called RECIST), the reported data shows that no participants had a complete disappearance of their tumour in any cohort. One participant in Cohort 2 was reported as having a partial response (meaning their tumour shrank by at least 30%). Three participants in Cohort 2 and one in Cohort 1 appeared in what seems to be a stable disease category, though the data as submitted is partially incomplete for some cohort rows in this outcome. The data for the remaining tumour-response categories across several cohorts was not fully reported. The reported data also includes technical measurements about how the radioactive antibody moved through the body. The average time for the antibody to clear from the whole body was reported as approximately 220 hours, with variation reported around that figure. Average radiation doses to normal organs ranged from about 0.056 to 0.18 cGy per unit of administered radioactivity, and the average total radiation dose reaching tumours was reported as approximately 13.8 Gray across all patients. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01927497 · results posted 17 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01927497) enrolled 104 people in total — 50 in a group who received a biological mesh closure of the perineal wound (the wound in the area between the legs after bowel surgery), and 54 in a group who had a standard primary perineal closure. The trial was measuring how well the perineal wound healed within 30 days after surgery. "Uncomplicated healing" was defined using a standard wound-scoring system (the Southampton wound score), where a score below a certain level indicated the wound was healing without significant problems. The reported data shows that in the biological mesh group, 30 out of 50 participants were recorded as having uncomplicated perineal wound healing at 30 days. In the standard closure group, 33 out of 54 participants were recorded as having uncomplicated wound healing at the same point. No additional outcome measures were included in the submitted results data beyond this primary measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01876901 · results posted 4 August 2021

  According to the results reported on ClinicalTrials.gov, this trial compared two surgical approaches for bowel reconnection after rectal cancer surgery. One group (65 people) received a two-stage pull-through procedure without a temporary stoma bag (called 2SCA), and the other group (59 people) received a standard bowel reconnection procedure (called CAA). The main thing the trial was measuring was how many people in the 2SCA group did not develop a serious leak at the join site within 30 days of surgery — a complication that would require a stoma (a surgically created opening in the abdomen to divert waste into a bag). The reported data shows that in the 2SCA group, only 1 out of the participants assessed had a symptomatic (noticeable, requiring treatment) leak at the join site within 30 days. Regarding stoma use, the reported data shows that 2 people in the 2SCA group required a stoma compared with 49 people in the CAA group (noting that a temporary stoma is a routine part of the standard CAA procedure). On post-operative complications, 13 people in the 2SCA group and 10 in the CAA group were reported to have had at least one surgical complication. No deaths within 30 days were recorded in either group. At 6 months after surgery, 25 people in the 2SCA group and 32 in the CAA group were reported to have some level of bowel control difficulty. For disease progression (cancer returning or spreading), the reported data shows that at one year, approximately 76.5% of the 2SCA group and 92.2% of the CAA group had no recorded progression; at two years, those figures were approximately 63.3% and 81.3% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01767857 · results posted 29 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01767857) enrolled 430 people in the Xilonix group and 213 people in the placebo group — a total of 643 participants. The trial was measuring a number of things in people with cancer, including how long participants lived overall, whether their body composition changed (specifically the amount of lean, or muscle-related, body mass), how they rated their symptoms and quality of life, changes in platelet counts (tiny blood cells involved in clotting), how long they went without their disease getting worse, and whether their tumours shrank. The reported data shows that for the main measure — overall survival (how long participants lived from the time they joined the trial) — the median time (the middle point where half had passed away and half had not) was 5.6 months in the Xilonix group and 5.4 months in the placebo group. For progression-free survival (time before the disease got worse or death occurred), both groups had a median of 2.1 months. The reported data shows that no participants in either group had their tumour shrink or disappear (0% objective response in both groups). For lean body mass, participants in the Xilonix group showed an average increase of 0.51 kg from the start, while the placebo group showed an average decrease of 0.21 kg. Changes in platelet counts showed an average increase of 5.50 units in the Xilonix group and 16.19 units in the placebo group. For the quality-of-life and symptom questionnaire scores (where higher scores generally indicate better health), the reported data shows small differences between the two groups across the pain, fatigue, appetite loss, and overall quality-of-life measures, with both groups generally showing changes in a similar direction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03728348 · results posted 4 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03728348) enrolled 983 people aged 45 to 49 who were considered to be at average risk. The study was testing a stool-based screening tool called a multi-target stool DNA test, which analyses a bowel motion sample for certain DNA changes and blood traces that can be associated with bowel abnormalities. Participants also had a colonoscopy (a camera examination of the bowel) so that the stool test results could be compared against that reference procedure. Of the 983 people who started, 842 completed all study procedures. The reported data shows that the trial measured something called "specificity" as its primary outcome. In plain terms, specificity describes how often the test correctly returns a negative (all-clear) result in people who did not have a concerning finding on colonoscopy. According to the results reported on ClinicalTrials.gov, the stool DNA test returned a specificity of 95.3% in this group — meaning that, among participants whose colonoscopy found nothing of concern, the stool test also came back negative in approximately 95 out of every 100 of those people. The remaining roughly 5 in 100 received a positive stool test result despite a clear colonoscopy. No other outcome measure results appear to have been submitted in the data provided, so figures for any secondary outcomes were not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02550743 · results posted 12 March 2021

  According to the results reported on ClinicalTrials.gov, this trial was testing a drug called BYL719 and was looking at two main things: the highest dose that could be given without causing unacceptable side effects (called the "maximum tolerated dose"), and whether participants with rectal cancer showed a complete disappearance of cancer cells in tissue samples taken after treatment. A total of 7 people took part across three dose groups — 3 people received Dose 1, 3 people received Dose 2, and 1 person received Dose 3. No participants were enrolled in a fourth planned group (Dose -1). All 7 participants who started the trial completed it. The reported data shows that for the primary goal — determining the maximum tolerated dose of BYL719 — the result was listed as "NA" (not available), meaning a clear maximum tolerated dose was not established or reported in the submitted data. For the secondary goal, the reported data shows that zero participants across all dose groups had a complete disappearance of cancer cells in their tissue samples after treatment. Because so few people took part overall, the trial was very small in scale, and no further outcome figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02292758 · results posted 28 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02292758) enrolled 36 people in total — 19 in one group and 17 in another. All participants completed the study period. The trial was comparing two treatment combinations in people with cancer: one group received irinotecan, cetuximab, and bevacizumab together, while the other group received irinotecan, cetuximab, and a placebo (an inactive substitute) instead of bevacizumab. The main things being measured were how long participants went without their cancer growing or spreading (called "progression-free survival"), and the proportion of participants who reached the 6-month and 12-month marks without that happening. The reported data shows that, for the main outcome of median progression-free survival — that is, the midpoint time before cancer showed signs of growing — the group receiving bevacizumab reached 9.7 months, compared with 5.5 months in the placebo group. Looking at the percentage of participants who had not experienced cancer progression at 6 months, the reported figures were 76.5% in the bevacizumab group and 41.2% in the placebo group. At 12 months, those figures were 27.5% and 17.6% respectively. For overall survival (how long participants lived), the reported median was 19.7 months in the bevacizumab group and 10.2 months in the placebo group. The reported data also shows that at 12, 18, and 24 months, the percentages of participants still alive were 77.2%, 56.1%, and 14.0% in the bevacizumab group, and 47.1%, 11.8%, and 5.9% in the placebo group. A measure called "disease control rate" — the proportion of participants whose cancer did not grow significantly — was reported as 68.4% in the bevacizumab group and 52.9% in the placebo group. On a secondary safety-related measure, 9 out of 19 participants in the bevacizumab group and 6 out of 17 in the placebo group experienced at least one serious side effect (graded as "grade 3 or higher," meaning severe or worse on a standard medical scale). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT03560128 · results posted 8 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 306 participants in each of two groups — one group had their colonoscopy performed using a device called AmplifEYE, and the other used a device called Endocuff Vision. Both are add-on attachments fitted to the tip of a colonoscope (the camera used to examine the bowel) that are designed to help the camera see behind folds in the bowel wall. The trial was measuring how many growths called adenomas (a type of bowel polyp) were found, along with a range of other things such as how many participants had at least one adenoma or polyp found, how long the procedure took, and any complications that occurred. The reported data shows that, on average, 1.63 adenomas per colonoscopy were detected in the AmplifEYE group, compared with 1.51 in the Endocuff Vision group. Looking at how many people had at least one adenoma found, the reported figures were 164 participants in the AmplifEYE group and 159 in the Endocuff Vision group. For polyps more broadly, 229 participants in the AmplifEYE group and 231 in the Endocuff Vision group had at least one polyp detected. The average number of polyps found per procedure was 2.71 for AmplifEYE and 2.55 for Endocuff Vision. Procedure times were also very similar between the two groups — for example, total procedure time was reported as 21.1 minutes for AmplifEYE and 21.5 minutes for Endocuff Vision. The reported data also shows that small areas of mucosal trauma (superficial scratches to the bowel lining) occurred in 30 participants in the AmplifEYE group and 24 in the Endocuff Vision group. No perforations (holes in the bowel wall) or gastrointestinal bleeding events were reported in either group. In a small number of cases, the device needed to be temporarily removed to pass through a curved section of the bowel called the sigmoid colon — this occurred in 17 participants using AmplifEYE and 15 using Endocuff Vision. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01220999 · results posted 23 September 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01220999) enrolled 19 people in total, spread across five groups (called cohorts) of 2, 4, 5, 3, and 5 participants respectively. Eighteen of the 19 participants completed the study. The trial was measuring how a drug called CS-1008 — tagged with a small amount of a radioactive tracer (called ¹¹¹In-CS-1008) so it could be tracked inside the body — moved through the bloodstream and whether it travelled to tumour sites. Researchers used special camera imaging and blood sampling at multiple time points over about six weeks to gather this information. The reported data shows that when tumour uptake was counted by participant, the numbers varied across cohorts. After the first infusion (on Day 1), 0 out of 2 participants in Cohort 1, 3 out of 4 in Cohort 2, 3 out of 5 in Cohort 3, 3 out of 3 in Cohort 4, and 3 out of 5 in Cohort 5 showed the tracer reaching tumour lesions. After the second infusion (on Day 36), the reported counts were 2, 1, 2, 0, and 2 participants across the five cohorts respectively. The reported data also shows the average amount of tracer that reached tumours was very small — roughly 0.004 to 0.006 percent of the injected dose per gram of tissue, depending on the cohort and time point. For the drug's behaviour in the bloodstream, the reported figures suggest it was cleared in two phases: a shorter early phase (ranging from about 5 to 22 hours across cohorts) and a much longer later phase (roughly 163 to 285 hours). Other blood-level measurements — including how much space the drug occupied in the bloodstream and how quickly it was cleared — were also reported and varied by cohort and dose level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01572428 · results posted 8 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 804 people in total — 402 in each of two groups. One group had their colonoscopy performed using a technique called Narrow-Band Imaging (NBI), which uses a special light to highlight tissue in the bowel, while the other group had a standard white-light colonoscopy. The trial was measuring how many specific types of polyps (growths in the bowel) called "serrated lesions" were found in the upper part of the large bowel, and also how many conventional adenomas (another type of polyp) were detected across the whole bowel. The vast majority of participants completed the trial — 399 in the NBI group and 401 in the standard white-light group. The reported data shows that, for serrated lesions found in the upper part of the bowel, the NBI group had a total of 204 detected compared with 158 in the standard white-light group. On average, that worked out to 0.51 serrated lesions per person in the NBI group and 0.39 per person in the standard white-light group. When looking at how many participants had at least one such serrated lesion, the reported figures were 105 people in the NBI group and 107 in the standard white-light group. For conventional adenomas found anywhere in the bowel, the reported totals were very similar — 438 in the NBI group and 434 in the standard white-light group — averaging 1.1 per person in the NBI group and 1.08 per person in the standard white-light group. The number of participants found to have at least one conventional adenoma was 202 in the NBI group and 189 in the standard white-light group. It is worth noting that the data as submitted to ClinicalTrials.gov includes multiple sets of measurements for each outcome, which may reflect results recorded at different time points or in different subgroups; however, the specific labels for those additional measurement sets were not provided in the available data, so they cannot be described in further detail here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02788279 · results posted 18 June 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 363 people with a type of cancer who were randomly assigned to one of three treatment groups: Regorafenib (90 people), a combination of Cobimetinib and Atezolizumab (183 people), or Atezolizumab alone (90 people). The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked several other things including how long it took for the cancer to get worse, how many people's cancer shrank during treatment, how long any shrinkage lasted, and how participants rated their own quality of life and physical functioning using a standard questionnaire. The reported data shows that the median overall survival — meaning the point in time by which half of the participants in each group had died — was 8.51 months in the Regorafenib group, 8.87 months in the Cobimetinib and Atezolizumab group, and 7.10 months in the Atezolizumab-alone group. When looking at how long it took for the cancer to progress or for a participant to die (whichever came first), the reported median times were very similar across all three groups: 2.00 months, 1.91 months, and 1.94 months respectively. The percentage of participants whose cancer showed a measurable reduction in size was reported as 2.2% in the Regorafenib group, 2.7% in the Cobimetinib and Atezolizumab group, and 2.2% in the Atezolizumab group. Among those who did respond, the reported median duration of that response was 4.50 months, 1.97 months, and 2.81 months respectively. For both quality-of-life measures — physical functioning and overall quality of life — all three groups reported scores that were lower than their starting point over time, meaning participants on average rated these as declining; the exact pattern across time points was not straightforward to summarise from the data as submitted, and some specific time-point figures were not clearly labelled in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02743221 · results posted 16 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 154 people in total — 77 in each group. Participants were randomly assigned to receive one of two combination treatments: either trifluridine/tipiracil plus bevacizumab, or capecitabine plus bevacizumab. The trial was measuring how long people went without their cancer growing (called progression-free survival), as well as several other outcomes including how long people lived overall, how many people's tumours shrank, and how long those responses lasted. The reported data shows that, for the main outcome — the time from the start of treatment until the cancer grew or a person died — the trifluridine/tipiracil plus bevacizumab group had a reported median (middle value) of 9.2 months, compared with 7.8 months in the capecitabine plus bevacizumab group. For overall survival, the reported median was 18.0 months in the trifluridine/tipiracil plus bevacizumab group and 16.2 months in the capecitabine plus bevacizumab group. The reported data shows that 26 out of 77 participants in the first group and 23 out of 77 in the second group had their tumours shrink or disappear. Among those whose tumours responded, the reported median duration of that response was 7.9 months in the first group and 9.9 months in the second group. The number of participants whose disease was reported as controlled (tumour shrank, disappeared, or stayed stable) was 66 in the first group and 59 in the second group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01830621 · results posted 11 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01830621) enrolled 282 people with advanced cancer — 138 received a drug called BBI608 and 144 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how long participants lived overall, how long it took for their disease to get worse, whether their disease showed any sign of responding or stabilising, side effects experienced, and how participants rated their own quality of life. The reported data shows that for overall survival — the length of time from joining the trial until death — the BBI608 group had a median (the midpoint value, where half lived longer and half shorter) of 4.44 months, compared with 4.76 months in the placebo group. For progression-free survival — the time until the disease was recorded as getting worse or the person died — both groups had an identical median of 1.82 months. For disease control rate, meaning the number of people whose disease completely disappeared, shrank, or stayed stable, 17 out of 138 people in the BBI608 group and 18 out of 144 in the placebo group met that measure. Regarding side effects, 135 of 138 people in the BBI608 group and 139 of 144 in the placebo group experienced at least one adverse event (an unwanted or unexpected medical occurrence noted during the trial). The reported data shows that quality-of-life scores — measured on a scale of 0 to 100 where higher means better — fell by approximately 10.61 points in the BBI608 group and 10.66 points in the placebo group over the first eight weeks, meaning both groups reported a similar decline in their quality of life from their starting scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01732783 · results posted 20 August 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01732783) enrolled 213 people in total across three treatment groups: 164 people received panitumumab combined with a chemotherapy regimen called FOLFOX as a first treatment, 37 received panitumumab combined with a different chemotherapy regimen called FOLFIRI as a second treatment (after an earlier treatment), and 12 received panitumumab with FOLFIRI as a first treatment. The trial was primarily measuring how panitumumab — a type of cancer medicine given through a drip — was actually used in practice, including how many infusions people received, the doses given, and how long they received the treatment. The reported data shows the following across the three groups. The median number of panitumumab infusions received was 10 for the first two groups and 8 for the third group. The middle-range total dose of panitumumab received was approximately 4,263 mg, 4,000 mg, and 3,783 mg respectively. The longest single dose recorded was 450 mg, 420 mg, and 507 mg in each group. The reported data shows that the time from a person's first to last panitumumab infusion was around 5.3 months, 6.0 months, and 5.3 months across the three groups. Regarding dose reductions, 36.6% of people in the first group, 21.6% in the second group, and 50% in the third group had at least one reduction in their panitumumab dose at some point during the trial. The mean interval between infusions was not reported as a single summary figure in the data provided. It is worth noting that of the 213 people who started the trial, only 36 completed it (29, 5, and 2 across the three groups respectively) — the data does not explain the reasons for non-completion in the structured results provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02508077 · results posted 16 August 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02508077) enrolled only one participant. The study was testing a combination of two treatments — panitumumab and a chemotherapy regimen called FOLFIRI — in people with a specific type of cancer. The main thing the trial set out to measure was the "4-month progression-free survival rate," which means the percentage of participants whose cancer had not grown or spread, and who had not died, by the 4-month mark after starting treatment. The reported data shows that the 4-month progression-free survival rate was 0%. In plain terms, this means that the one person enrolled in the trial had experienced either disease progression (their cancer had grown or spread by a defined amount) or had died before reaching the 4-month point. Because only a single participant took part and the trial ended with just that one person completing it, the numbers reported here are based on an extremely small sample. No secondary outcome measures appear to have been reported in the submitted data. It is worth noting that a trial of just one participant is far too small to draw any meaningful conclusions about how a treatment performs, and the results as submitted reflect only that single individual's experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02448810 · results posted 19 March 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02448810) enrolled 85 people in total across two parts. Part 1 involved 12 participants who were each given the investigational drug imalumab combined with one of two other cancer medicines (either 5-FU/LV or panitumumab) at two different dose levels. The main goal of Part 1 was to check whether any serious early side effects — called "dose-limiting toxicities" — occurred in the first 28 days of treatment. Part 2 enrolled 73 participants across four groups and was focused on measuring how long people went without their cancer growing or spreading, which is known as "progression-free survival" (PFS). The reported data shows that in Part 1, zero out of 12 participants across all four groups experienced a dose-limiting toxicity during the initial treatment period. In Part 2, the reported median PFS — meaning the point in time by which half the participants in each group had experienced disease progression or died — was 11.1 weeks for the imalumab plus 5-FU/LV group, compared with 8.3 weeks for the standard-of-care comparison group with similar tumour characteristics. For the imalumab plus panitumumab group, median PFS was reported as 9.3 weeks, compared with 7.3 weeks in its corresponding standard-of-care comparison group. Notably, the reported data shows that zero participants were recorded as having "completed" the study in any group, meaning all participants either withdrew, were lost to follow-up, or the study ended before individual completion was recorded. The reported data also shows that across both parts of the trial, serious adverse events (unexpected or significant medical events) were recorded in a number of participants — for example, 15 out of 29 treated participants in the Part 2 imalumab plus 5-FU/LV group and 8 out of 13 in the Part 2 standard-of-care mutant group. One participant in the Part 2 imalumab plus panitumumab group developed antibodies against imalumab (proteins the body produced in response to the drug), and one participant in that same group experienced an infusion reaction (a reaction during or shortly after the drug was given by drip). No complete or partial tumour responses (where tumours shrank measurably) were reported in Part 2; in Part 1, two participants in the 7.5 mg/kg imalumab plus panitumumab group recorded a partial response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02119676 · results posted 14 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 396 participants across two sub-studies, all of whom had cancer and were being treated with a drug called regorafenib. In each sub-study, participants were randomly assigned to also receive either ruxolitinib or a placebo (a dummy treatment with no active ingredient). The trial's main goal was to measure how long participants lived overall (called "overall survival"), and it also tracked several other things, including how long it took for the cancer to get worse, whether tumours shrank, and what side effects were experienced. The reported data shows that, for overall survival — the main measure — the estimated midpoint survival time (meaning half of participants lived longer than this, and half did not) was 4.6 months in the Substudy 1 ruxolitinib group and 5.3 months in the Substudy 1 placebo group. In Substudy 2, those figures were 11.4 months and 10.9 months respectively. For the secondary measure of how long before the cancer showed signs of worsening, the reported midpoint times were 2.2 months (Substudy 1 ruxolitinib), 2.1 months (Substudy 1 placebo), 3.5 months (Substudy 2 ruxolitinib), and 2.0 months (Substudy 2 placebo). No participants in Substudy 1 had their tumours shrink, while in Substudy 2 approximately 2.7% and 4.5% of participants in the ruxolitinib and placebo groups respectively had tumours shrink. Duration of response data was not reported. All or nearly all participants across every group experienced at least one treatment-emergent side effect (an unwanted effect that started or worsened after treatment began), according to the reported figures. The reported data also shows that when "disease control" — meaning tumours that either shrank or stayed stable rather than growing — was measured, 40.2% of the Substudy 1 ruxolitinib group and 34.1% of the Substudy 1 placebo group achieved this, while in Substudy 2 the figures were 61.8% and 36.9% respectively. These numbers describe what was observed and recorded in this specific group of trial participants and do not on their own tell us whether one treatment is better than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00468910 · results posted 31 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 79 people in total — 40 in the aspirin (acetylsalicylic acid) group and 39 in the placebo group. Of those, 36 in each group completed the study. The trial was measuring whether aspirin, taken over three months, produced changes in certain biological markers in colon tissue. These markers — called SPEC and FRAC — are measurements of the tiny physical structure of cells at a microscopic level, and were being studied as potential indicators related to bowel cancer development. The trial also looked at cell death rates, cell growth rates, and levels of a substance called prostaglandin in the bowel lining. The reported data shows the following numbers for the two main (primary) markers. For SPEC, the aspirin group started at 40.72 and measured 43.45 after three months, while the placebo group started at 37.54 and measured 37.52. For FRAC, the aspirin group started at 142.41 and measured -407.78 after three months, while the placebo group started at 23.28 and measured 650.97. For the secondary measures, the reported data shows that the percentage of cells undergoing a type of cell death (measured by a marker called cleaved caspase 3) was 4.56% at the start and 4.26% at three months in the aspirin group, compared with 5.24% and 7.26% in the placebo group. Cell growth (measured by Ki67) was 38.07% rising to 43.60% in the aspirin group, and 40.45% falling to 37.74% in the placebo group. Prostaglandin levels started at 305.93 and fell to 211.97 in the aspirin group, compared with 654.64 falling to 209.02 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01671488 · results posted 12 May 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01671488) enrolled 11 people, all of whom received the study treatment — a combination of an investigational drug called ADXS11-001 together with standard chemotherapy drugs (Mitomycin and 5-FU) and a type of targeted radiation called IMRT, for anal cancer. Ten of the 11 participants completed the study, and one did not finish. The trial was measuring two main things: the side effects experienced by participants, and whether tumours showed no signs of remaining disease (called a "complete response") at the six-month mark. The reported data shows that, of the 10 participants assessed for side effects, all 10 had adverse events (unwanted health events) recorded — these were captured from the time participants agreed to join the trial through to four weeks after treatment ended, regardless of whether the events were thought to be caused by the treatment. For the six-month tumour assessment, the reported data shows that 9 out of 10 evaluated participants were recorded as having a complete response, meaning no detectable tumour was found at that point. The trial also tracked a secondary measure — how long participants went without their disease getting worse, and how long they survived overall — with 8 participants reported under that outcome, though specific survival time figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02277093 · results posted 1 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, all of whom completed the study. The trial was testing a drug called pacritinib and was primarily measuring how long participants went without their disease getting worse (called progression-free survival). It also tracked how long it took for the disease to progress, how long participants lived overall, how many participants' tumours responded to the treatment, and what unwanted side effects occurred. The reported data shows that the median time before the disease got worse — that is, the middle value across all participants — was about 1.91 months for progression-free survival, and 1.73 months for time to progression specifically. The median overall survival (how long participants lived from the start of treatment) was reported as approximately 6.61 months. For overall response — meaning how participants' tumours changed — the reported data shows that 0 participants had a complete response (tumour disappearing entirely), 0 had a partial response (tumour shrinking significantly), 1 had stable disease (tumour neither growing nor shrinking enough to count as either), 6 had progressive disease (tumour grew), and 4 were listed in another category. Regarding side effects, the reported data shows 8 individual adverse events (unwanted reactions) were recorded that were considered at least possibly related to the treatment and were of a moderate severity or higher, though the specific nature of each event was not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01490866 · results posted 12 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people, all of whom received a combination treatment involving chemotherapy drugs (FOLFOX and Bevacizumab) followed by a maintenance drug called Axitinib. The trial was measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as other things like how many people's tumours shrank, how long before the disease worsened, and how long people lived overall. All 70 participants started the first phase of treatment, and 49 went on to the maintenance phase with Axitinib. The reported data shows that, on average, participants went 8.3 months before their disease progressed or they died — this is the primary result the trial was designed to measure. For the secondary results, the reported time until the disease worsened (measured slightly differently) was 8.8 months on average, and the average overall survival — meaning the time from first treatment until death from any cause — was reported as 24.2 months. Regarding tumour response, the reported data shows two figures for the objective response rate (the percentage of people whose tumours shrank meaningfully): 34% and 57% — however, it is not clear from the submitted data what specific patient groups or time points these two figures refer to, so they cannot be described further without risk of misrepresentation. The reported data also recorded how many participants experienced unwanted side effects (called adverse events). Among the 70 people in the chemotherapy phase, various numbers of participants experienced different types of side effects, with figures ranging from 22 to 40 people depending on the specific event. Among the 48 people in the Axitinib maintenance phase, those numbers ranged from 0 to 24 people. The full breakdown of what each specific side effect was is not detailed in the submitted results data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00527111 · results posted 3 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 139 people in total — 70 in a group that received a combination of chemotherapy, radiotherapy, and a medicine called cetuximab, and 69 in a group that received chemotherapy and radiotherapy alone. The trial was measuring whether adding cetuximab to standard chemoradiotherapy made a difference in tumour response and longer-term outcomes for people with rectal cancer. Around 50 people in the first group and 47 in the second group completed the study. The reported data shows that for the main goal of the trial — the proportion of participants whose tumours showed no remaining signs of invasive disease after treatment (called a "complete pathologic response") — the figures were almost identical: 26.6% in the cetuximab group and 26.7% in the chemoradiotherapy-alone group. For the secondary measures, the reported data shows that 52.2% of the cetuximab group and 43.5% of the chemoradiotherapy-alone group had their tumours shrink meaningfully or disappear based on scans. When it came to survival over five years, the reported probability of still being alive at five years was 0.81 (roughly 81 in 100) in the cetuximab group and 0.68 (roughly 68 in 100) in the chemoradiotherapy-alone group. The reported probability of being alive and free from the cancer returning at five years was 0.65 in the cetuximab group and 0.585 in the chemoradiotherapy-alone group. The trial also recorded that 32.5% of participants in the cetuximab group and 44.0% in the chemoradiotherapy-alone group had a particular gene change (KRAS mutation), which is sometimes relevant to how certain medicines interact with cancer cells. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00002525 · results posted 20 July 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 855 people with colon cancer — 427 were assigned to receive a chemotherapy drug called 5-FU around the time of their surgery (the "perioperative 5-FU" group), and 428 were assigned to receive no such treatment. Participants fell into different cancer stage groups — known as Dukes' B2, B3, or C — which reflect how far the cancer had spread. The trial was measuring how many people in each group were still alive five years later, and how many had gone that long without their cancer coming back or a new cancer appearing. The reported data shows the following figures for the more advanced cancer stages (Dukes' B3 or C): in the perioperative 5-FU group, about 66.6 in every 100 participants (0.666 as a proportion) were still alive at five years, compared with about 61.2 in every 100 (0.612) in the no-treatment group. For going five years without the cancer returning or a new cancer developing, the reported figures were about 58.2 in every 100 (0.582) in the 5-FU group versus about 54.3 in every 100 (0.543) in the no-treatment group. For the less advanced stage (Dukes' B2), the reported five-year survival figures were about 85.1 in every 100 (0.851) in the 5-FU group and about 78.0 in every 100 (0.780) in the no-treatment group, while the figures for going five years without cancer returning were about 74.9 in every 100 (0.749) versus about 72.4 in every 100 (0.724) respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00009737 · results posted 22 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,004 people in the Capecitabine group and 983 people in the 5-Fluorouracil + Leucovorin (5-FU/LV) group — a total of 1,987 participants — all of whom had colon cancer. The trial was comparing two chemotherapy treatments given after surgery, measuring things like how long participants went without their cancer returning, how long they survived overall, and their quality of life during treatment. The reported data shows that for the main measure — disease-free survival (the number of participants who did not experience a cancer relapse, a new colon cancer, or death during the study period) — 656 out of 1,004 people in the Capecitabine group and 603 out of 983 people in the 5-FU/LV group were counted in this category. For relapse-free survival (similar, but excluding deaths unrelated to the treatment or cancer), the reported numbers were 677 in the Capecitabine group and 621 in the 5-FU/LV group. For overall survival (participants known to be alive at the end of the tracking period), the reported figures were 804 in the Capecitabine group and 756 in the 5-FU/LV group. Regarding quality of life, both groups showed a small average improvement in their self-reported general health score at week 25 — a change of 2.1 points for Capecitabine and 2.6 points for 5-FU/LV, on a scale from 0 to 100. The reported data also shows that 910 participants in the Capecitabine group and 885 in the 5-FU/LV group experienced at least one adverse event (an unwanted medical occurrence during the study), while serious adverse events were recorded for 181 and 182 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01979029 · results posted 6 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 57 people in total — 29 in one group and 28 in another. All participants completed the study with no dropouts. The trial compared two different surgical approaches used during bowel surgery: one called "High Ligation of IMA" (where a main blood vessel supplying the lower bowel is tied off higher up) and another called "Left Colic Artery Preserved" (where a branch of that blood vessel is kept intact). The main thing the trial was measuring was the blood pressure inside a small network of blood vessels in the bowel (called the "arterial arcade") after the surgery, to see whether it differed between the two approaches. The reported data shows that the average blood pressure measured in the bowel's arterial arcade was 42.31 mmHg (millimetres of mercury, a standard unit for measuring pressure) in the High Ligation group, compared to 48.50 mmHg in the Left Colic Artery Preserved group. For a secondary measurement — the length of bowel remaining below the surgical site — the reported figures were an average of 20.03 cm in the High Ligation group and 21.29 cm in the Left Colic Artery Preserved group. An additional measurement recorded the participants' general body blood pressure, which was reported as 82.86 mmHg on average in the High Ligation group and 81.21 mmHg in the Left Colic Artery Preserved group, suggesting the two groups had broadly similar overall blood pressure levels during the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01507103 · results posted 2 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 124 people in total, split across three groups: 41 received chemoradiotherapy combined with a vaccine called tecemotide (L-BLP25) and a drug called cyclophosphamide; 41 received chemoradiotherapy and tecemotide without cyclophosphamide; and 42 received chemoradiotherapy alone. All participants who started the trial also completed it. The trial was measuring how the immune system responded to these treatments — specifically, whether certain immune cells (called tumour-infiltrating lymphocytes, or TILs, which are cells that move into tumour tissue) changed between the start of the trial and after surgery, and whether other markers of immune activity in the blood or tumour changed over time. The reported data shows that for the main measure — the change in TILs per 100 tumour cells from the start to after surgery — the chemoradiotherapy-only group had the highest numbers at both time points (1.538 at baseline and 0.936 after surgery), compared to the tecemotide-plus-cyclophosphamide group (0.609 at baseline and 0.565 after surgery) and the tecemotide-only group (0.543 at baseline and 0.216 after surgery). For a secondary measure looking at immune cells circulating in the blood, small changes were recorded across all three groups, with figures close to zero on a technical measurement scale. The reported data shows that results for two other planned primary measures — involving a laboratory test called ELISpot that tracks a specific immune signal — were not reported in the submitted data, so those figures are not available. Regarding a separate analysis of a genetic marker called microsatellite instability (MSI), which can affect how tumours behave, the reported data shows that most participants in all three groups fell into the "MSI absent" category (25, 32, and 30 people respectively), with only a small number showing MSI present (2, 1, and 0 respectively). Several other secondary measures, including detailed analysis of immune cells around the tumour's edges, also had no numerical results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00332163 · results posted 23 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people in total — 48 in a "pre-emptive skin treatment" group (who received skin care before any skin problems appeared) and 47 in a "reactive skin treatment" group (who received skin care only after skin problems developed). All 95 participants completed the trial. The study was looking at skin-related side effects in people receiving the cancer drug panitumumab, specifically comparing whether starting skin care early or waiting until problems arose made a difference in the number and severity of those side effects over a six-week period. The reported data shows that, for the main outcome — the proportion of people who experienced moderate-to-severe skin reactions from a specific list of types — 29% of participants in the pre-emptive group and 62% in the reactive group had these reactions. For a broader measure covering any moderate-to-severe skin reaction of any type, the reported figures were 40% in the pre-emptive group and 62% in the reactive group. When looking at how quickly reactions appeared, the data was not reported for the pre-emptive group, while in the reactive group the first such reaction appeared at around 2.1 weeks on average. Regarding the worst reactions reached: in the pre-emptive group, 23% of participants reached a Grade 2 reaction and 6% reached Grade 3, compared with 40% and 21% respectively in the reactive group; no participants in either group reached Grade 4 (described as life-threatening) in these specific skin categories. The reported data also shows that 6% of participants in the pre-emptive group and 11% in the reactive group had their panitumumab dose reduced due to these skin reactions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00069095 · results posted 22 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,034 people across six treatment groups. Participants received one of two chemotherapy combinations — XELOX or FOLFOX-4 — either on their own, with a placebo, or with an additional medicine called bevacizumab (BV). The main thing the trial was measuring was "progression-free survival" — that is, how many days passed from the start of treatment before a participant's disease got worse or they died. The trial was designed to look at two questions: whether XELOX performed at a similar level to FOLFOX-4 (a "non-inferiority" comparison), and whether adding bevacizumab to chemotherapy made a difference compared to chemotherapy plus placebo. The reported data shows the following day counts for the primary outcome (time before disease worsened or death, as judged by the treating doctors): the FOLFOX-4 group recorded a median of 259 days, while the XELOX group recorded 241 days. For the same measure assessed by an independent review committee rather than the treating doctors, the reported figures were 304 days for FOLFOX-4 and 261 days for XELOX. When comparing the placebo-containing groups to the bevacizumab-containing groups (as assessed by the independent committee), the reported figures were 259 days for chemotherapy plus placebo and 335 days for chemotherapy plus bevacizumab. Additional analyses using slightly different counting methods reported similar patterns across these comparisons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01697449 · results posted 16 October 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 191 people with colorectal cancer (CRC). Of those, 101 completed the study and 90 did not. The trial was measuring a range of things, including how often participants experienced unwanted or unexpected signs or symptoms (called adverse events), how their tumours responded to treatment, and how long it was before their disease got worse or they passed away. The reported data shows that 15.2% of participants experienced at least one adverse event — that is, an unwanted or unintended sign, symptom, or disease noted during the study. When it came to tumour response, the results were broken down by whether a participant's cancer was considered operable (resectable) or not operable (unresectable) at the start. Among those whose cancer was considered operable or potentially operable at the start, 72% were reported to have had a complete response (tumour disappears), a partial response (tumour shrinks by at least 30%), or stable disease (tumour neither grew nor shrank enough to count as either). Among those whose cancer was considered inoperable at the start, 69% were reported to fall into those same categories. Additionally, the reported data shows that 34.5% of participants whose cancer was initially considered inoperable were later assessed as potentially operable. Across the whole group, 76.5% of participants experienced disease progression or died during the study period. The reported median progression-free survival — meaning the midpoint time before disease got worse or death occurred — was 9 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01651949 · results posted 9 March 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,520 participants across three groups: 1,106 heterosexual males, 1,101 females, and 313 men who have sex with men (MSM). The trial was measuring how the body responded to a 9-strain HPV (human papillomavirus) vaccine — specifically looking at antibody levels in the blood after vaccination, as well as tracking any side effects or unwanted physical changes that occurred around the time of vaccination. Participants received three doses of the vaccine and were followed throughout. The reported data shows that antibody levels (a measure of the body's immune response to the vaccine, expressed in laboratory units called milli Merck Units per millilitre) varied across the groups and across the nine HPV strains tested. For example, for one HPV strain (HPV 16), reported antibody levels were 3,346 units in heterosexual males, 2,788 units in females, and 2,294 units in MSM. The secondary outcome reported that between approximately 99.4% and 100% of participants across all three groups reached a pre-set antibody threshold (called "seroconversion") for the HPV strains measured. Regarding tracked physical changes around the time of vaccination, the reported data shows that 66.7% of males and 84.0% of females recorded at least one injection-site reaction (such as pain, redness, or swelling) on their report card. A raised temperature (38°C or above) was recorded by 4.4% of males and 5.9% of females. Overall, 76.2% of males and 89.4% of females reported at least one unwanted physical change during the study period. The proportion of participants who had the vaccine course stopped due to an unwanted physical change was reported as 0.1% for males and 0.3% for females. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00682786 · results posted 8 September 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 135 people with rectal cancer — 98 in a group called "Good Risk" and 37 in a "Poor Risk" group. These labels refer to a genetic variation in a gene called Thymidylate Synthase (TYMS), which influences how the body processes certain chemotherapy medicines. The trial was investigating whether knowing a patient's genetic type could help predict how well their tumour responded to chemotherapy and radiation given before surgery (known as neoadjuvant chemoradiation). Most participants completed the study — 96 in the Good Risk group and 34 in the Poor Risk group. The reported data shows that the primary thing being measured was "tumour downstaging" — meaning the tumour shrank by at least one stage after treatment. Historical studies had recorded a downstaging rate of around 45%. In this trial, the reported downstaging rate was 64.4% in the Good Risk group and 64.5% in the Poor Risk group. For secondary outcomes, the trial also measured how many participants had no detectable tumour remaining after treatment. The reported data shows that in the Good Risk group, 20% had no tumour left in the rectum, compared with 41.9% in the Poor Risk group. When looking at no tumour in either the rectum or nearby lymph nodes, the figures were 18.9% (Good Risk) and 35.5% (Poor Risk). Two other secondary outcomes — about patients' quality of life and their views on genetic testing — were measured by questionnaire, but no numerical results were reported in the data. For overall survival, figures reported at what appear to be different time points were 96.9% and 80.6% and 78.2% for the Good Risk group, and 94.3%, 94.3%, and 83.6% for the Poor Risk group, though the specific time points for each figure were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00911170 · results posted 7 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 847 people in total — 424 in the placebo group and 423 in the pegfilgrastim group. The trial was looking at whether pegfilgrastim (a medicine sometimes given alongside chemotherapy) made a difference to the rate of a serious complication called febrile neutropenia — a fever combined with a very low white blood cell count — during the first four cycles of chemotherapy. Participants also received bevacizumab as part of their cancer treatment. The trial also tracked how long participants lived overall, how long before their cancer progressed, and how many had their tumour shrink or disappear. The reported data shows that for the main question — the rate of Grade 3/4 febrile neutropenia (the more severe forms) across the first four chemotherapy cycles — 5.7% of people in the placebo group experienced this, compared with 2.4% in the pegfilgrastim group. For the even more severe category (Grade 4 only), the figures were 3.5% in the placebo group and 2.4% in the pegfilgrastim group. Regarding how long participants lived overall (overall survival), the reported median — meaning the midpoint figure for the group — was 24.6 months in the placebo group and 21.8 months in the pegfilgrastim group. The median time before the cancer progressed or death occurred (progression-free survival) was reported as 10.1 months for the placebo group and 9.7 months for the pegfilgrastim group. The percentage of participants whose tumour shrank or disappeared (objective response) was reported as 56.7% in the placebo group and 58.1% in the pegfilgrastim group. No data was reported for the long-term follow-up phase — the results show zero completions in both groups for that period, and no further explanation was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01289821 · results posted 4 September 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all of whom received a combination treatment of regorafenib plus a chemotherapy regimen known as mFOLFOX6 (made up of oxaliplatin, folinic acid, and 5-fluorouracil). The trial was measuring how tumours responded to this combination, how long participants lived, and how long it took before their disease got worse. Notably, none of the 54 participants completed the treatment period itself, though most went on to complete a safety follow-up phase. The reported data shows that the main outcome being tracked — called "objective response" — was recorded in approximately 44% of participants (a proportion of 0.439). This means that just under half of participants had their tumours either disappear completely or shrink by at least 30% based on scan measurements. For a broader measure called "disease control" — which also counted participants whose tumours stayed stable and did not grow — the reported proportion was approximately 85% (0.854). The reported data also shows that the median time before disease worsened or death occurred (progression-free survival) was 258 days, and the median time that a response to treatment lasted was 257 days. For participants whose tumours stayed stable without shrinking, that stability lasted a median of 231 days. The median overall survival — the midpoint for how long participants lived from the start of treatment — was reported as 772 days. These figures are summary numbers reported across the whole group of 54 participants; individual experiences would have varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00851084 · results posted 25 June 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00851084) enrolled 236 people with cancer — 117 in a group receiving a chemotherapy regimen called mFOLFOX6 on its own, and 119 in a group receiving mFOLFOX6 combined with a drug called aflibercept. The trial was designed to measure how many participants were still alive without their disease getting worse at 12 months, as well as several other outcomes including how long until the disease progressed, how many participants showed a measurable tumour response, how long participants survived overall, and what unwanted medical events occurred. Importantly, the trial was not designed to formally compare the two groups against each other — it was set up to describe each group separately. The reported data shows that at the 12-month mark, 21.2% of participants in the chemotherapy-only group and 25.8% in the combination group were alive without their disease having progressed — meaning roughly one in five and one in four people respectively. The reported time until disease progression (on average, based on a statistical estimation method) was approximately 8.77 months in the chemotherapy-only group and 8.48 months in the combination group. For tumour response (participants whose tumours shrank by a meaningful amount or disappeared), the reported data shows 45.9% in the chemotherapy-only group and 49.1% in the combination group. The reported data shows that overall survival (time from the start of the trial until death from any cause) was approximately 22.31 months in the chemotherapy-only group and 19.45 months in the combination group. Regarding unwanted medical events, 115 out of 117 participants in the chemotherapy-only group and all 119 in the combination group reported at least one such event during treatment, with the full breakdown of severity levels not clearly separable from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01032291 · results posted 21 May 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at two drugs — lenalidomide and cetuximab — in people with a type of cancer. The trial had two stages. The first stage (the "Safety Lead-in") enrolled 8 people and was designed to work out a safe starting dose of lenalidomide to use in combination with cetuximab. The second stage (the "Proof of Concept" period) enrolled 43 people across two groups: 22 received lenalidomide alone and 21 received lenalidomide combined with cetuximab. The trial was ended earlier than planned. The reported data shows that in the first stage, 1 out of the 8 participants experienced what is called a "dose-limiting toxicity" — meaning a side effect serious enough to potentially limit how much of the drug could be given. Because fewer than 2 of the first 6 participants had this experience, the trial proceeded to its second stage using the higher 25 mg dose of lenalidomide. For the second stage, researchers tracked how tumours responded to treatment using standardised measurements. The reported data shows that no participants in either group had a complete response (full disappearance of tumours) or a partial response (meaningful shrinkage). In the lenalidomide-only group, 3 participants had stable disease and 13 had progressive disease (tumours grew); 5 participants had no data reported. In the lenalidomide-plus-cetuximab group, 5 had stable disease, 13 had progressive disease, and 3 had no data reported. Several other planned measurements — including survival time, duration of response, and disease control rates — were not reported because the study was terminated early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00308516 · results posted 14 May 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 66 people in total who had rectal cancer. They were split into two groups: 35 people received treatment (a combination of chemotherapy, radiation, and a drug called bevacizumab) **before** surgery, and 31 people received the same combination **after** surgery. The trial was primarily looking at how many people in each group were still alive and showed no signs of their cancer coming back at 24 months after finishing their treatment. The reported data shows that, for the primary measure — being alive and free of returning disease at 24 months — 85% of participants in the pre-surgery treatment group and 97% of participants in the post-surgery treatment group reached that point without evidence of disease recurrence. It is worth noting that the number of participants who completed the study was relatively small (6 in the pre-surgery group and 21 in the post-surgery group), with many participants not completing the study for reasons not detailed in this data. For the secondary measure — how long in total participants survived from the start of treatment — the reported data shows these figures were not reported (marked as "NA" in the submitted results). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00384176 · results posted 28 November 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,614 people across three groups: 709 received cediranib at a 20 mg dose, 713 received bevacizumab at 5 mg/kg, and 192 received cediranib at a 30 mg dose. The trial was primarily measuring how long participants went without their cancer getting worse (called "progression-free survival"), and also tracked a number of other things including overall survival, tumour shrinkage, and quality of life. It is worth noting that results for the cediranib 30 mg group were not reported in the data submitted to ClinicalTrials.gov, so only the 20 mg cediranib and bevacizumab groups are described in the findings below. The reported data shows that for the primary measure — time until the cancer progressed or the person died — the cediranib 20 mg group had a reported median of 9.9 months, while the bevacizumab group had a reported median of 10.3 months. ("Median" here means the midpoint figure — half of participants experienced the event before this time, and half after.) For overall survival (time from the start of the trial until death from any cause), the reported figures were 22.8 months for cediranib 20 mg and 21.3 months for bevacizumab. Regarding tumour response, 328 participants in the cediranib 20 mg group and 337 in the bevacizumab group were reported to have had their tumours shrink by a meaningful amount. The duration of that shrinkage was reported as 8.6 months for cediranib 20 mg and 9.6 months for bevacizumab. Tumour size at the first check (around week 8) was reported to have decreased by an average of 23.2% in the cediranib 20 mg group and 22.1% in the bevacizumab group. The reported data also shows that time until participants' quality of life (as measured by a bowel cancer symptom questionnaire) got noticeably worse was 170 days for the cediranib 20 mg group and 245 days for the bevacizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00399035 · results posted 30 October 2012

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called cediranib in people with advanced colorectal cancer. A total of 1,076 participants were enrolled across three groups: 502 people received cediranib at a dose of 20 mg per day, 216 received cediranib at 30 mg per day, and 358 received a placebo (a dummy treatment with no active ingredient). The trial's main focus was on two things: how long participants went without their cancer growing or spreading (called "progression-free survival"), and how long participants lived overall. It is worth noting that the reported outcome results only compare the 20 mg cediranib group with the placebo group — figures for the 30 mg group were not reported in the results data. The reported data shows that for progression-free survival, the cediranib 20 mg group had a median (middle value across the group) of 8.6 months, compared with 8.2 months in the placebo group. For overall survival, the reported median was 19.7 months in the cediranib 20 mg group and 18.9 months in the placebo group. For the secondary outcomes, the best recorded shrinkage in tumour size was reported as a reduction of about 42.5% in the cediranib group and about 40.6% in the placebo group. The duration of tumour response — meaning how long a response lasted in those who had one — was reported as 8.5 months for cediranib and 6.9 months for placebo. Additionally, 21 participants in the cediranib group and 17 in the placebo group underwent surgery to remove cancer that had spread to the liver. The overall response rate was reported as a participant count (254 in the cediranib group, 178 in the placebo group), though the breakdown needed to interpret this figure fully was not included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00439517 · results posted 14 June 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 302 people in total — 152 in one group and 150 in another. All participants had colorectal cancer, and the trial compared two chemotherapy combinations, each paired with a targeted medicine called cetuximab: one group received a regimen called UFOX plus cetuximab, and the other received a regimen called FOLFOX4 plus cetuximab. The main thing the trial was measuring was how long participants went without their cancer growing or spreading (called "progression-free survival"). The reported data shows that, on average, participants in the UFOX plus cetuximab group went 6.6 months before their disease progressed or they died, compared with 8.2 months in the FOLFOX4 plus cetuximab group. When looking at how many participants' tumours shrank or disappeared (the "best overall response"), the reported figures were 37.5% in the UFOX group and 51.3% in the FOLFOX4 group. For overall survival — the time from the start of the trial until death — two sets of figures were reported: one set showed 12.9 months and 15.5 months respectively, and a second set showed 16.8 months and 18.4 months (the reason for two separate overall survival figures was not explained in the submitted data). Quality-of-life scores were also measured using two questionnaires at multiple time points; both groups recorded broadly similar scores across those time points, with only small numerical differences between them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00457691 · results posted 3 June 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 768 people with colorectal cancer — 386 received a chemotherapy combination called FOLFIRI together with a drug called sunitinib, and 382 received FOLFIRI together with a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how long participants went without their cancer growing or spreading — called "progression-free survival" — and also tracked how long participants lived overall, how many showed a measurable reduction in their tumour, how long those responses lasted, and how participants rated their symptoms over time. The reported data shows that, for the main measure, the FOLFIRI plus sunitinib group went a median (middle value) of 33.6 weeks before their cancer progressed or they died, compared with 36.6 weeks in the FOLFIRI plus placebo group. For overall survival, the reported figures were 87.9 weeks in the sunitinib group and 85.9 weeks in the placebo group. When looking at tumour response, 124 participants in the sunitinib group and 128 in the placebo group showed a confirmed reduction in tumour size. The reported duration of that response was 30.1 weeks in the sunitinib group and 39.0 weeks in the placebo group. For the symptom and quality-of-life scores, the reported data shows multiple measurement points across time; the detailed figures varied between groups and time points, and no single summary figure was provided for the full study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  Read the full trial page

• NCT00729677 · results posted 18 March 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people who had colorectal cancer and were about to start chemotherapy. All 64 participants completed the study — none dropped out. The trial was looking at how often nausea occurred during the first week of chemotherapy, broken down by gender and by whether participants had a previous history of nausea. It also looked at how nausea and vomiting affected participants' day-to-day quality of life, measured using a standard questionnaire called the Functional Living Index – Emesis Scale (a tool where higher scores indicate a greater impact on quality of life). The reported data shows that, among participants who experienced nausea in the first week of chemotherapy, 64% of females, 34% of males, and 100% of transgender participants reported nausea — though it is worth noting the transgender group likely represented a very small number of people, so that 100% figure should be interpreted with caution. Regarding history of nausea, the reported data shows that 14 participants with a prior history of nausea reported nausea during the first week, compared to 17 participants with no prior history of nausea who also reported nausea. Additionally, 9 participants with a history of nausea and 24 without such a history did not report nausea. The quality-of-life questionnaire results were not reported in the data submitted to ClinicalTrials.gov. A further analysis reported that 24 participants on a two-drug anti-nausea medication regimen and 6 on a three-drug regimen reported nausea, while 26 on the two-drug regimen and 8 on the three-drug regimen did not. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT00101686 · results posted 26 November 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 547 participants across ten treatment groups. People were assigned to different combinations of chemotherapy regimens — called FOLFIRI, mIFL, and CapeIRI — along with either a drug called celecoxib or a placebo (a dummy pill with no active ingredient), and some groups also received a drug called bevacizumab. The main thing the trial was measuring was "time to progression" — that is, how many months passed before a person's cancer showed signs of growing or spreading again. The reported data shows that, for the two main groups compared in the primary (main) measure, people in the FOLFIRI group had a reported median time to progression of 8.18 months, while those in the mIFL group had 6.01 months. When a third regimen, CapeIRI, was included in a broader comparison, the reported figures were 7.62 months for FOLFIRI, 5.98 months for mIFL, and 5.82 months for CapeIRI. The reported data also shows that the number of participants who had a measurable tumour response was 68 (FOLFIRI), 61 (mIFL), and 56 (CapeIRI). Reported survival times averaged 23.06 months for FOLFIRI, 17.64 months for mIFL, and 18.92 months for CapeIRI. When comparing celecoxib versus placebo across the study, the reported time to progression was 6.64 months for the celecoxib group and 6.70 months for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

See the full Colorectal Cancer page · What changed recently

Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.