Reported trial results for Oesophageal Cancer
Every Oesophageal Cancer trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
52 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
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NCT04540211 · results posted 9 April 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04540211) enrolled 461 people in total — 232 in the placebo group (placebo plus chemotherapy drugs paclitaxel and carboplatin, referred to as PC) and 229 in the combination group (atezolizumab and tiragolumab plus the same chemotherapy). The trial was primarily measuring two things: how long participants went without their cancer growing or spreading (called progression-free survival, or PFS), and how long participants lived overall (called overall survival, or OS). It is worth noting that no participants were recorded as having formally "completed" the trial, meaning all participants either left the trial early or were still in follow-up when results were submitted. The reported data shows that for the main measure of progression-free survival — assessed by an independent review panel — the placebo group had a median of 5.39 months before disease progressed or death occurred, compared with 6.18 months in the atezolizumab and tiragolumab group. (Median means the point at which half the participants had reached that outcome and half had not.) For overall survival, the reported median was 11.10 months in the placebo group and 15.74 months in the combination group. A secondary, investigator-assessed measure of progression-free survival reported 5.45 months for the placebo group and 7.00 months for the combination group. The reported data also shows results for tumour response rates — the percentage of participants whose tumours shrank by a meaningful amount. Using the independent review panel's assessment, 45.5% of the placebo group and 59.7% of the combination group had a recorded response. Investigators' own assessments gave figures of 41.4% and 55.9% respectively. Among those who did respond, the reported median duration of that response (how long it lasted) was 4.34 months in the placebo group and 7.10 months in the combination 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 ↗
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NCT03611309 · results posted 8 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03611309) enrolled 359 people in total — 182 in a group where patients were cared for jointly by their surgeon and a palliative care team, and 177 in a group managed by their surgeon alone. The trial was looking at whether adding a palliative care team alongside the surgeon made a difference to patients' quality of life, mood, spiritual wellbeing, symptom burden, understanding of their prognosis, and survival over six months, all measured after cancer-related surgery. The reported data shows that for the main outcome — quality of life scored on a 46-question scale running from 0 to 184 (where higher means better) — participants in the joint care group scored an average of 138.54, and those in the surgeon-alone group scored 136.90 at 12 weeks after surgery. For mental and physical health (measured on a standardised scale where 0 represents the average of the general population, and negative numbers mean below that average), both groups scored similarly: around -0.50 and -0.43 for physical health, and -0.07 in both groups for mental health. Spiritual wellbeing, scored on a 0–48 scale, was nearly identical between the two groups (35.90 versus 35.89). For symptom burden (pain, tiredness, nausea, and others rated 0–10), the reported data shows no numbers were submitted to ClinicalTrials.gov. Regarding survival at six months, 164 participants in the joint care group and 156 in the surgeon-alone group were reported as surviving, with 7 and 6 deaths recorded respectively in each 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 ↗
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NCT03641313 · results posted 8 July 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — irinotecan and M6620 — given to people with a type of cancer being studied in a single treatment group. A total of 17 people enrolled in the trial, 12 completed it, and 5 did not finish. The trial's main goal was to measure the "objective response rate" — that is, how many participants' tumours either shrank significantly (a "partial response") or disappeared completely (a "complete response") according to standard imaging-based criteria. The reported data shows that, out of all 17 participants, zero achieved either a partial or complete tumour response. Because no responses were recorded, the secondary measure of "how long responses lasted" could not be calculated and was not reported. For the remaining secondary measures, the reported data shows that the average time until the cancer was recorded as growing or spreading ("time to progression") was 3.5 months; the average length of time participants lived without their cancer progressing ("progression-free survival") was approximately 4 months; and the average overall survival — meaning how long participants lived from the start of the trial — was reported as approximately 6.2 months. When participants were split into two sub-groups based on whether their cancer had previously responded to a different type of chemotherapy (platinum-based treatment), zero participants in either sub-group recorded a tumour 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 ↗ · Linked publication on PubMed ↗
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NCT04752358 · results posted 4 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — two people with oesophageal cancer and one person with oesophagogastric junction cancer (where the oesophagus meets the stomach), giving a total of three participants. The trial was investigating a T-cell based treatment and was designed to measure how well tumours responded to the treatment, how long any response lasted, and what unwanted medical events (called adverse events) occurred during the study. Notably, none of the three participants completed the study. The reported data shows that because the trial closed early with so few participants, most of the planned outcome measurements — including the primary goal of measuring tumour response rates, as well as time to response, duration of response, best overall response, and progression-free survival — were not reported (no numbers were submitted for these measures). For the adverse events outcome, the reported data shows that all three participants (two in the oesophageal group and one in the oesophagogastric junction group) experienced at least one adverse event. One participant from each group experienced a serious adverse event. One participant in the oesophagogastric junction group experienced an adverse event in a special category of interest. No cases of two specific serious side effects — cytokine release syndrome (an overreaction of the immune system) or ICANS (a type of neurological reaction) — were reported in either 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.
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NCT03430843 · results posted 29 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03430843) enrolled 256 participants in each group — one group received a medicine called tislelizumab, and the other received chemotherapy chosen by their doctor (referred to as "investigator chosen chemotherapy"). The trial was measuring how long participants lived overall, how long they lived before their cancer got worse, and how many participants' tumours shrank or disappeared. Results were looked at for all participants combined (the "ITT" group) and separately for a smaller group whose tumours tested positive for a protein called PD-L1 (meaning their tumours showed a certain biological marker). The reported data shows that, for overall survival (how long participants lived from the start of the trial), the tislelizumab group had a reported median of 8.6 months compared with 6.3 months in the chemotherapy group across all participants. Among the PD-L1 positive participants only, those figures were 10.2 months versus 5.1 months respectively. For tumour shrinkage (the percentage of participants whose tumour fully or partially shrank), the reported data shows 20.3% in the tislelizumab group versus 9.8% in the chemotherapy group across all participants, and 26.3% versus 11.3% in the PD-L1 positive group. For progression-free survival (how long before the cancer got worse or a participant died), the reported figures across all participants were 1.6 months for tislelizumab and 2.1 months for chemotherapy; in the PD-L1 positive group, they were 2.7 months and 2.3 months respectively. No participants were recorded as having "completed" the study in the standard sense, as the trial's design meant all participants exited the study before a formal completion milestone was reached. 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 ↗
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NCT02609425 · results posted 24 November 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, and all 30 completed the study with none dropping out. The trial was looking at a specific type of surgical suture (stitch) called Stratafix, used during an oesophagectomy — an operation to remove part or all of the oesophagus (the tube connecting the throat to the stomach). The study was measuring two things after surgery: whether a leak occurred at the join where the oesophagus was reconnected (called an anastomotic leak), and whether that join later became too narrow, causing a blockage (called an anastomotic stricture). The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either of these two outcome measures. The fields for the actual measurements — both for leak rate and stricture rate — were left empty in the results data. Because those figures were not reported, it is not possible to describe what the numbers showed for either outcome. This means that, based on what has been submitted to ClinicalTrials.gov, the specific findings from this study are not publicly available in a form that can be summarised or compared. If you are looking for the detailed results, it may be worth searching for any published journal article linked to this trial, or speaking with a health professional who can help locate further information. 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 ↗
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NCT03783442 · results posted 7 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03783442) enrolled 649 people — 326 in the tislelizumab plus chemotherapy group and 323 in the placebo plus chemotherapy group. The trial was measuring outcomes for people with oesophageal cancer. The main thing researchers were tracking was **overall survival** — that is, how long participants lived from the time they joined the trial. Several secondary measures were also tracked, including how long it took for the disease to get worse (progression-free survival), how many participants showed a measurable reduction in their tumour (objective response rate), how long any response lasted (duration of response), a look at survival in a specific subgroup, and changes in quality-of-life symptoms such as difficulty swallowing, eating, reflux, and pain. The reported data shows that the median overall survival — meaning the point at which half the participants in each group had passed away — was **17.2 months** in the tislelizumab plus chemotherapy group, compared with **10.6 months** in the placebo plus chemotherapy group. For progression-free survival, the reported median was **7.3 months** versus **5.6 months**. The reported data shows that **63.5%** of participants in the tislelizumab group had a measurable tumour reduction (complete or partial response), compared with **42.4%** in the placebo group. The median duration of that response was reported as **7.1 months** versus **5.7 months**. In a subgroup of participants whose tumours had a particular protein marker (PD-L1 score of 10% or above), the reported median overall survival was **16.6 months** in the tislelizumab group and **10.0 months** in the placebo group. For the quality-of-life symptom scores, small changes from starting levels were reported in both groups across measures such as swallowing difficulty, eating, reflux, and pain, though the data presented does not clearly match each number to a specific timepoint or subscale. 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 ↗
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NCT03709706 · results posted 7 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03709706) enrolled 34 people across two groups: 20 participants received a treatment called lete-cel on its own (Arm A), and 14 received lete-cel combined with another medicine called pembrolizumab (Arm C). The trial was studying a type of cell therapy for cancer, and it was primarily measuring unwanted medical events (called adverse events) that occurred after treatment, as well as whether participants' tumours shrank or disappeared (called the overall response rate). Only a smaller subgroup — 7 people in Arm A and 6 in Arm C — actually received the cell infusion and were included in the main safety analysis. The reported data shows that all 7 participants in Arm A and all 6 in Arm C who received the infusion experienced at least one adverse event after treatment. Serious adverse events were reported in 5 people in Arm A and 3 people in Arm C. When graded by how severe those events were, the numbers varied across mild, moderate, severe, and life-threatening categories across both groups, with the full breakdown recorded in the submission. Adverse events of special interest — a pre-defined list of concerns such as immune reactions and blood cell problems — were recorded in 6 participants in each group. In terms of tumour response, the reported data shows that zero participants in either group had their tumours shrink or disappear, giving an overall response rate of 0% in both arms. The reported median time before disease got worse or participants passed away was approximately 5.3 months in Arm A and 1.5 months in Arm C. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02530437 · results posted 10 July 2023
According to the results reported on ClinicalTrials.gov, this was a Phase 1B clinical trial that enrolled 7 participants. All 7 completed the study. The trial was looking at a combination treatment involving a drug called taladegib given together with two chemotherapy medicines (paclitaxel and carboplatin) and radiation therapy, in people with oesophageal cancer. The main things being measured were how often certain side effects occurred that were serious enough to limit the dose (called "dose-limiting toxicities"), and whether participants had no detectable cancer remaining in the tissue removed at surgery — known as a pathologic complete response. The reported data shows that, out of the 7 participants, 4 were recorded under one measurement entry for pathologic complete response and 3 under another, though the data as submitted does not clearly separate these into distinct subgroups with fuller explanation. For the secondary outcomes, the reported data shows a relapse-free survival figure of 14 months and an overall survival figure of 27 months — these numbers represent how long, on average, participants went without their cancer returning, and how long they survived overall, respectively. The safety outcome (dose-limiting toxicities) and the biomarker results were not reported in the structured data submitted to ClinicalTrials.gov. It is worth noting that with only 7 participants, this was a very small, early-phase study, and the numbers above reflect that small group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02965976 · results posted 16 February 2023
According to the results reported on ClinicalTrials.gov, this trial looked at whether injecting Botulinum Toxin Type A (commonly known as Botox) during oesophageal surgery (removal of the oesophagus, or food pipe) might affect a condition called delayed gastric emptying — where the stomach is slow to move food through after surgery. A total of 32 people took part: 15 were in the group that received the Botox injection alongside their surgery, and 17 had surgery alone. Of those who started, 13 in the Botox group and all 17 in the surgery-only group completed the study. The reported data shows that for the main thing being measured — delayed gastric emptying as detected by a nuclear medicine scan — 12 out of 15 participants in the Botox group and 14 out of 17 in the surgery-only group showed delayed emptying, while 1 person in the Botox group and 3 in the surgery-only group did not show delayed emptying. A second scan method (a swallow or CT scan done around day 7 after surgery) returned the same numbers. For days until participants were able to eat solid food again, the reported average was around 22.6 days in the Botox group and 27 days in the surgery-only group. The reported average hospital stay was 7.9 days for the Botox group and 8.1 days for the surgery-only group. Regarding whether a follow-up procedure was needed due to slow stomach emptying within 90 days, 1 person in the Botox group and 0 in the surgery-only group required one, while 10 in the Botox group and 15 in the surgery-only group did not. Finally, for lung-related events connected to slow stomach emptying, 3 people in each group experienced such an event, while 9 in the Botox group and 13 in the surgery-only group 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.
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NCT03814824 · results posted 7 October 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 133 people in total — 67 in one group and 66 in the other. It was a crossover study, meaning each participant experienced both approaches being compared: a type of scan called VLE (Volumetric Laser Endomicroscopy) used on its own, and VLE used together with a feature called IRIS (Intelligent Real-time Image Segmentation). The trial was measuring how long it took doctors to review and interpret the scan images, using that time as a way to gauge how easy the images were to read. It also looked at how many participants had a finding called dysplasia (abnormal cells) detected through tissue samples taken during each approach. The reported data shows that, for the group that started without IRIS and then used IRIS, average image review time was 4.0 minutes without IRIS and 3.8 minutes with IRIS. For the group that started with IRIS and then went without, average review time was 4.6 minutes with IRIS and 2.4 minutes without IRIS. When the review time was adjusted to account for the length of the area being examined (reported as centimetres per minute), the reported figures ranged from 0.6 to 1.3 across the different groups and phases. For the secondary outcome — the number of participants where dysplasia was found in tissue samples — the reported data shows 29 participants had dysplasia detected using VLE without IRIS, 34 using VLE with IRIS, and 24 using the standard biopsy method (called the Seattle Protocol, which involves taking samples at regular intervals). 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 ↗
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NCT03417570 · results posted 29 July 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people in total — 50 in each group. All 100 participants completed the study with no dropouts. The trial was comparing two versions of the same stomach and oesophagus camera examination (called an endoscopy): one performed with a small plastic cap fitted to the tip of the camera, and one performed without that cap. Each participant underwent both versions of the procedure. The main thing being measured was how many participants had abnormal tissue changes in their oesophagus (known as Barrett's oesophagus) that were spotted and then confirmed by a tissue sample as being a specific type of concerning change — ranging from low-grade changes through to early cancer. The reported data shows that, for the primary measurement, 56 participants had these tissue changes identified during the examination without the cap, while 60 participants had them identified during the examination with the cap. For the secondary measurements, the same pattern of 56 (without cap) versus 60 (with cap) was reported for the number of participants with any visible abnormal areas spotted. When looking specifically at participants with the more serious findings — high-grade changes or early oesophageal cancer — the reported numbers were 22 (without cap) and 23 (with cap). The reported data shows that the average time for each procedure was very similar: approximately 161 seconds without the cap and approximately 160 seconds with the cap. Regarding procedure-related unwanted events (side effects or complications), the reported data shows that zero participants in either group experienced any such events during the procedure or in the 48 hours afterwards, though the trial noted these events were recorded for the overall experience rather than separately for each part of 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.
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NCT02872116 · results posted 28 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02872116) enrolled a total of 2,031 participants across three treatment groups: one group received nivolumab (an immunotherapy medicine) combined with chemotherapy (789 people), one group received chemotherapy alone (833 people), and one group received nivolumab combined with another immunotherapy called ipilimumab (409 people). The trial was studying treatments for gastric (stomach) and related cancers. The main things being measured were how long participants lived overall (called "overall survival"), and how long they went before their cancer got worse or they died (called "progression-free survival"). Some of these measurements were focused on participants whose tumours showed a particular protein marker, called PD-L1 CPS, at certain levels. The reported data shows that, among participants whose tumours had a PD-L1 CPS score of 5 or higher, the median overall survival — that is, the midpoint time at which half the participants in each group had died — was reported as approximately 14.4 months in the nivolumab-plus-chemotherapy group, compared with approximately 11.1 months in the chemotherapy-alone group. For progression-free survival in that same group, the reported median was approximately 7.7 months for nivolumab plus chemotherapy, compared with approximately 6.1 months for chemotherapy alone. When looking at all participants regardless of their PD-L1 marker level, overall survival medians ranged from around 13.7 to 15.0 months for the nivolumab-plus-chemotherapy group and around 10.9 to 11.6 months for chemotherapy alone across the different subgroups reported. The reported data shows that the proportion of participants whose tumours shrank (the "objective response rate") was approximately 47–50% in the nivolumab-plus-chemotherapy group, compared with approximately 37–38% in the chemotherapy-alone group, depending on the subgroup. For time to worsening of stomach cancer symptoms, the data was not reported for the nivolumab-plus-chemotherapy group, while the chemotherapy-alone group had a reported median of approximately 21 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03335813 · results posted 9 June 2022
According to the results reported on ClinicalTrials.gov, seven people took part in this trial, which tested a type of internal radiation treatment called brachytherapy, delivered using a multichannel balloon applicator placed inside the lung. Six participants completed the trial and one did not. The trial was measuring how precisely and fully the radiation dose could be delivered to the tumour, and how much radiation reached nearby organs such as the heart, aorta (the main blood vessel from the heart), and the airway (bronchus). The reported data shows that, on average, 90% of the tumour volume received at least 105.5% of the intended prescription dose — meaning the target area received slightly more than the planned amount. Additionally, 94.3% of the tumour volume received 100% or more of the prescription dose. The total volume of tissue — tumour plus surrounding normal tissue — receiving the full prescription dose was reported as about 52 cubic centimetres on average. These figures reflect how the radiation was distributed across the treatment area. For nearby organs, the reported data shows the average radiation dose reaching a small (1 cubic centimetre) portion of the airway was 2.38 Gray (a unit used to measure radiation dose), measured only in the 4 participants whose tumours were close to the airway. For the 4 participants with tumours near the heart, the average dose to a small portion of the heart was 3.22 Gray. For the 6 participants with tumours near the aorta, the average dose to a small portion of the aorta was 3.19 Gray. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02971956 · results posted 8 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 participants, all of whom completed the study. Every participant received pembrolizumab, an immunotherapy drug. The trial was measuring how often the tumours responded to treatment, how long participants went without their disease getting worse, how long participants lived overall, and how many experienced serious side effects linked to the treatment. The reported data shows that the overall response rate — meaning the proportion of participants whose tumours either disappeared completely or shrank by a meaningful amount — was 0.08, or roughly 8 out of every 100 participants (about 4 people out of the 49). For the time-related outcomes, the reported median time before the disease progressed or a participant died was 1.8 months, and the reported median overall survival — the midpoint for how long participants lived from the time they entered the study — was 5.8 months. ("Median" simply means the middle value: half of participants experienced the outcome before that time point, and half after.) Regarding serious side effects considered related to the treatment, the reported data shows that 6 out of 49 participants experienced at least one grade 3 or 4 adverse event, which refers to severe or life-threatening reactions as classified by a standard medical rating 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.
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NCT03143153 · results posted 2 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03143153) enrolled 970 people across three treatment groups: 325 received a combination of nivolumab and ipilimumab (two immunotherapy medicines), 321 received nivolumab combined with chemotherapy, and 324 received chemotherapy alone. The trial was measuring two main things: how long participants lived overall (called "overall survival"), and how long they lived without their cancer growing or spreading (called "progression-free survival," meaning the time before the disease got worse or the person passed away). These main measures were looked at first in participants whose tumours showed a particular protein marker (called PD-L1), and then across all participants. The reported data shows that, among participants whose tumours had the PD-L1 marker, the median overall survival — that is, the midpoint time at which half the participants in each group had passed away — was reported as approximately 13.7 months for the nivolumab-plus-ipilimumab group, 15.4 months for the nivolumab-plus-chemotherapy group, and 9.1 months for the chemotherapy-alone group. The median time before disease worsened (progression-free survival) in this same group was reported as approximately 4.0 months, 6.9 months, and 4.4 months respectively. Across all participants regardless of PD-L1 marker status, the reported median overall survival figures were approximately 12.7, 13.2, and 10.7 months for the three groups, and median progression-free survival was approximately 2.9, 5.8, and 5.6 months. The reported data also shows that the proportion of participants whose tumours shrank noticeably (called the "objective response rate") varied across groups and across different subgroups measured in the trial, with figures ranging from around 20% to 53% depending on the group and the subgroup being reported. The reported data includes multiple sets of response rate figures, likely reflecting different subgroups, though the data as submitted does not label each set separately. No further breakdown of those figures 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01900691 · results posted 23 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 130 people who received an Evolution® Esophageal Stent — a type of mesh tube placed in the oesophagus (the food pipe). The trial was looking at two main things: first, whether the stent could be successfully removed using a camera procedure (endoscopy), and second, whether people who had a non-cancerous (benign) condition in their oesophagus reported an improvement in their swallowing difficulties or were able to eat and drink by mouth again. A total of 111 participants completed the study, while 19 did not. The reported data shows that, for the primary question about stent removal, 57 out of the first 58 participants who had an attempted removal had the stent taken out successfully in a single procedure — meaning the stent came out in one piece without visible damage to surrounding tissue that needed immediate treatment. For the secondary question, the reported data shows that 44 participants with benign (non-cancerous) conditions showed an improvement in swallowing symptoms or were able to take food or fluids by mouth. The total number of participants with benign conditions who were assessed for this outcome was not separately 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.
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NCT03245736 · results posted 4 November 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, all of whom received a drug called tisotumab vedotin. The trial was an extension study, meaning participants had already taken part in an earlier related trial. The main thing the trial was set up to measure was how many participants experienced what are called "treatment emergent adverse events" — that is, any unwanted medical occurrences that happened after starting the study drug or that got worse during the treatment period. None of the 5 participants completed the study. The reported data shows that all 5 participants experienced at least one treatment emergent adverse event. For the secondary measures, the trial also looked at how tumours responded to treatment using a standard set of criteria (called RECIST 1.1). Of the 5 participants, the reported data shows that 0 had a complete response (no detectable tumour), 2 had a partial response (some reduction in tumour size), 2 had stable disease (no significant change), and 1 had progressive disease (tumour growth). The trial also tracked a blood marker called CA-125, which can be associated with ovarian cancer — 1 participant showed an increase in this marker since the end of the earlier trial. For a similar marker related to prostate cancer (PSA), no 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.
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NCT02625610 · results posted 4 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02625610) enrolled 499 people — 250 in the chemotherapy plus best supportive care group and 249 in the avelumab group. The trial was measuring how long participants lived overall, how long they lived without their disease getting worse, how their tumours responded to treatment, and how they rated their own quality of life over time. The reported data shows that for the primary measure — overall survival, meaning the time from the start of the trial until death from any cause — the chemotherapy plus best supportive care group had a median (the midpoint value, where half lived longer and half lived shorter) of 10.9 months, while the avelumab group had a median of 10.4 months. For progression-free survival — the time until the disease was recorded as getting worse or until death — the reported medians were 4.4 months for the chemotherapy group and 3.2 months for the avelumab group. The proportion of participants whose tumours showed a measurable response (either complete disappearance or meaningful shrinkage) was reported as 14.4% in the chemotherapy group and 13.3% in the avelumab group. The reported data shows that for quality-of-life scores, participants in both groups completed questionnaires rating their health across areas such as mobility, pain, and anxiety on a standard scale. The changes from their starting scores were small in both groups across the follow-up period, with the data not showing large differences between the two groups at most time points; the specific numerical changes were not reported for all individual time points in a way that allows straightforward comparison. 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 ↗
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NCT02743494 · results posted 22 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02743494) enrolled 532 people in the nivolumab group and 262 people in the placebo group — a total of 794 participants. The trial was measuring two main things: how long people went without their disease coming back after surgery (called "disease-free survival"), and how long people lived overall (called "overall survival"). Participants were randomly assigned to receive either nivolumab or a placebo (an inactive treatment used for comparison). The reported data shows that, on average, people in the nivolumab group went approximately 22.4 months before their disease returned or they died, compared with approximately 11 months in the placebo group. For overall survival — meaning how long people lived from the time they joined the trial — the reported median figure was approximately 51.7 months in the nivolumab group and approximately 35.3 months in the placebo group. The reported data also shows the percentage of participants still alive at one, two, and three years: at 12 months, 87.5% (nivolumab) versus 84.6% (placebo); at 24 months, 68.1% versus 65.8%; and at 36 months, 56.9% versus 49.7%. These figures are averages across the trial population and describe what was measured in this specific study. It is important to note that these numbers are simply what was recorded and reported for this group of trial participants under these specific 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 ↗
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NCT01196390 · results posted 4 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 203 people with oesophageal (food pipe) cancer whose tumours tested positive for a protein called HER2. Participants were randomly placed into one of two groups: one group received standard chemoradiation (chemotherapy combined with radiation) plus a medicine called trastuzumab, and the other received chemoradiation alone. The trial was primarily looking at "disease-free survival" — that is, how long participants went without their cancer returning, spreading, or dying from any cause. The reported data shows that, on average, participants in the chemoradiation-plus-trastuzumab group went approximately 19.6 months without a disease event, compared with approximately 14.2 months in the chemoradiation-only group. These figures are estimates based on a statistical method called Kaplan-Meier, which accounts for participants who were still being followed up when the analysis was done. For overall survival (time from the start of the study until death from any cause), the reported figures were very similar between the two groups — approximately 38.5 months for the trastuzumab group and 38.9 months for the chemoradiation-only group. Among participants who went on to have surgery, 27% in the trastuzumab group and 29% in the chemoradiation-only group showed no remaining tumour in the removed tissue, a result called a pathologic complete response. Quality-adjusted survival data was not reported in the submitted results. Regarding quality of life, the reported data shows that after treatment, 46% of participants in the trastuzumab group and 38% in the chemoradiation-only group showed a meaningful improvement in one quality-of-life measure related to oesophageal cancer symptoms, though multiple time points were measured and figures varied across those time points. On side effects, small numbers of participants in both groups experienced the most serious recorded grades of side effects — 2 participants in the trastuzumab group and none in the chemoradiation-only group experienced a grade 5 (death-related) adverse event, while the majority in both groups fell into the moderate-to-serious range (grades 3–4). 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 ↗
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NCT01217060 · results posted 13 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01217060) enrolled 4 participants, all of whom received the same treatment: a combination of two chemotherapy drugs (docetaxel and 5-FU), radiation therapy, and then surgery. This approach is sometimes called "trimodality" treatment. The trial was designed to look at outcomes for people with an early-stage cancer of the oesophagus (the tube that carries food from the mouth to the stomach) or the junction where the oesophagus meets the stomach. Of the 4 people who started the trial, 3 completed it and 1 did not. The reported data shows that the trial had two things it set out to measure: first, whether there was a "pathologic complete response" — meaning no cancer cells could be found when the removed tissue was examined under a microscope after surgery — and second, how long participants went without their disease coming back or worsening (called "disease-free survival"). However, the data as submitted to ClinicalTrials.gov does not include any numerical results for either of these two measures. No figures were reported for either outcome, so it is not possible to describe what the results showed beyond the participant numbers above. It is worth noting that only 4 people took part in this trial, which is a very small number, and any findings would need to be interpreted with that context in mind. The absence of reported outcome numbers means no conclusions about the treatment's performance can be drawn from the publicly available 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.
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NCT03449030 · results posted 22 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03449030) tested a drug called TAK-164 in 31 adults in total. Participants were divided into ten groups, each receiving a different dose of TAK-164, ranging from very low to higher amounts. The trial was an early-stage study designed to find out how different doses of the drug affected participants and to identify what are called "dose-limiting toxicities" — that is, side effects serious enough at a given dose to limit how much could safely be given. No participant was recorded as having completed the study in the formal sense, meaning all participants left the study before the planned endpoint, which is not uncommon in this type of early trial. The reported data shows that across every dose group, 100% of participants experienced at least one adverse event (an unwanted health occurrence during the study). The proportion who experienced more severe adverse events (graded "Grade 3 or above," meaning serious or worse) varied by dose group: 0% in the lowest dose group, up to 100% in some of the higher dose groups. Drug-related adverse events — those the investigators considered linked to TAK-164 — were also reported across most groups, ranging from 0% to 100% depending on the dose. Serious adverse events were reported in several groups, ranging from 0% to 100% across the different dose levels. Regarding dose-limiting toxicities specifically, the reported data shows that 1 participant in the 0.19 mg/kg group and 2 participants in the 0.25 mg/kg group experienced these, while no dose-limiting toxicities were reported in the remaining eight groups. 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 ↗
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NCT01913639 · results posted 15 May 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people, all of whom received a combination treatment of FOLFOX (a chemotherapy regimen) plus Regorafenib (a targeted cancer medicine). The trial was measuring how long participants went without their disease getting worse (called progression-free survival), how long participants lived overall, and how many participants' tumours shrank or disappeared during treatment. Thirty-six people completed the trial, and three did not. The reported data shows that 53% of participants were free from their disease getting worse at the point measured by the trial. For overall survival — meaning the time from the start of treatment until death or the last check-in — the reported figure was 14.2 months on average across participants (this average was calculated using a statistical method called Kaplan-Meier, which estimates survival over time). The reported data also shows that 54% of participants had their tumours shrink or disappear (either completely or partially), based on standardised imaging criteria. All 39 participants were assessed for side effects, though the specific details of those side effects are not broken down further in the data 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.
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NCT01439594 · results posted 22 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01439594) enrolled 17 participants, all of whom completed the study with no drop-outs. The trial was looking at whether a particular imaging technique called OFDI (Optical Frequency Domain Imaging) could be used to take clear internal images of tissue and compare those images to standard biopsy samples taken during a procedure involving radiofrequency ablation — a technique that uses heat to treat tissue. The goal was to see if the imaging approach was practical and could produce usable pictures. The reported data shows that the primary outcome measured the number of successful imaging sessions. An imaging session was counted as successful if the OFDI device produced clear, readable images that could be meaningfully compared to biopsy results taken at the same time. The data lists two figures for this outcome — 64 and 29 imaging sessions — however, the submitted results do not clearly label what each of these two numbers separately represents (for example, whether one refers to total sessions attempted and the other to successful sessions, or some other breakdown). As such, the full context of these figures cannot be confirmed from the data as submitted. It is worth noting that the submitted results include only the primary outcome measure, and no secondary outcome data appears to have been reported for this trial on 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.
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NCT01498289 · results posted 29 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 202 people in total — 98 in Arm I (a chemotherapy regimen called FOLFOX) and 104 in Arm II (referred to as "IT"). The trial was looking at how long participants went without their cancer getting worse (called progression-free survival, or PFS) and how long they lived overall (overall survival). Participants were also grouped by their levels of a protein called ERCC1, which the researchers were interested in as a potential marker that might relate to how people respond to treatment. The reported data shows that among participants with high ERCC1 levels, the median time without disease progression was 4.7 months in Arm I and 5.3 months in Arm II. Among those with low ERCC1 levels, the reported figures were 5.9 months in Arm I and 2.8 months in Arm II. For overall survival across all participants, the reported median was 11.4 months in Arm I and 8.7 months in Arm II. For the secondary outcome of overall response rate — meaning the proportion of participants whose tumours shrank by a measurable amount — the reported figures were 42% in Arm I and 30% in Arm II. The trial also recorded serious side effects (Grade 3–5) considered possibly related to the study drugs; small numbers of participants in each arm experienced these, with the specific counts varying by type of side effect. It is worth noting that the data shows zero participants recorded as having "completed" the study in either arm, though this likely reflects how the trial's completion milestone was defined rather than meaning no one finished treatment — however, this detail was not further 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.
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NCT01477177 · results posted 15 May 2019
According to the results reported on ClinicalTrials.gov, this trial involved 4 participants, all of whom were in a single group receiving a treatment called the "Polar Wand." All 4 participants who started the trial completed it. The trial was looking at a condition called Barrett's oesophagus — a change in the lining of the food pipe that can sometimes be detected during a scope examination. The study aimed to measure whether the Polar Wand treatment changed the appearance and tissue classification of Barrett's oesophagus over time, as well as the length of the affected area in the food pipe. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures. This includes the primary outcome — changes in tissue classification at 12 months — as well as all secondary outcomes, which covered changes in the length of the affected area, any complications such as bleeding, perforation, or stricture, post-treatment symptoms such as chest pain or difficulty swallowing, and tissue classification at 6 months. Because no measurement data was provided in the submitted results, it is not possible to describe what those outcomes showed in numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02234180 · results posted 17 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02234180) enrolled a very small number of participants — just 3 people in total. Two were assigned to receive regorafenib (the study drug) and one received a placebo (a dummy treatment with no active ingredient). The trial was measuring how long people remained free of their disease returning after treatment (called "disease-free survival"), as well as tracking side effects and how long participants lived overall. The reported data shows that, across all participants combined, the median disease-free survival — meaning the midpoint time before disease came back or a participant passed away — was reported as approximately 4.83 months. For side effects, the reported data shows that 0% of participants experienced severe side effects (graded as level 3 or higher on a standard medical scale used to measure how serious side effects are) that were considered at least possibly related to the study treatment. For overall survival — the length of time participants lived from the start of the trial — the reported data shows this figure was listed as "not available," meaning it was not reported in the submitted results. It is worth noting that only 3 people took part in this trial, which is an extremely small number. This means the figures above are based on very limited data and should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01446874 · results posted 12 June 2018
According to the results reported on ClinicalTrials.gov, this trial looked at whether a toothbrushing routine before (and after) major chest surgery might be related to rates of lung infection (pneumonia) in the 30 days following the operation. A total of 150 people started the trial across three groups: 20 in an early pilot group who only followed a pre-surgery brushing routine, 50 who were having oesophageal (food-pipe) removal surgery and followed both pre- and post-surgery brushing routines, and 80 who were having lung removal surgery and also followed both routines. Of those who started, 18, 46, and 62 people respectively completed the study. The reported data shows that, for the primary outcome of post-operative pneumonia, 5 participants in the oesophageal surgery group and 1 participant in the lung surgery group met the criteria for pneumonia within 30 days of their operation (pneumonia figures were not reported separately for the pilot group). For the pilot group's primary measure — whether people actually followed the pre-surgery brushing routine — 16 out of 18 who completed that phase were recorded as having done so. On secondary outcomes, the reported data shows zero deaths among oesophageal surgery participants and 3 deaths among lung surgery participants during the study period. Regarding breathing complications after surgery (such as needing a breathing machine or a procedure to clear the airways), small numbers were recorded across both surgical groups, with figures generally ranging from 0 to 5 participants per category. Compliance tracking questionnaires were completed by 46 oesophageal surgery participants and 62 lung surgery 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 ↗ · Linked publication on PubMed ↗
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NCT02392377 · results posted 13 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02392377) involved two treatment groups: one receiving paclitaxel, carboplatin, radiation therapy, and surgery (Arm I), and one receiving a combination chemotherapy regimen, radiation therapy, and surgery (Arm II). The trial was designed to look at biological markers — specifically, patterns of gene activity and tiny molecules called microRNAs — in tumour samples, to see whether those patterns could be linked to how well patients responded to their treatment. Response was measured using a type of body scan called an FDG-PET scan, as well as by examining tissue removed during surgery. The reported data shows that only one participant was enrolled across both arms (zero in Arm I, one in Arm II), and that single participant did not complete the study. The reported data shows that no numerical results were recorded for any of the trial's primary or secondary outcome measures. This includes all planned analyses of gene expression patterns, microRNA profiles, and biological pathway activity — both at the start of treatment and after chemotherapy. Because the trial enrolled only one participant and that person did not complete it, none of the comparisons the study set out to make (for example, comparing scan responders to non-responders, or looking at tissue changes before and after treatment) could be carried out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01065818 · results posted 26 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received a radioactive imaging agent called Fluoro-L-Thymidine (FLT) as part of a PET scan (a type of body imaging). The trial was looking at patients undergoing neoadjuvant therapy — that is, treatment such as chemotherapy, radiotherapy, or a combination of both given before surgery — to explore the best timing for using FLT-PET scans to predict how a patient might respond to that treatment. Of the 6 people who started the trial, 4 completed it and 2 did not. The reported data shows that no numerical measurements were submitted to ClinicalTrials.gov for the primary outcome measure. In other words, while the trial recorded what it intended to measure — finding the optimal point during treatment at which an FLT-PET scan could predict treatment response — no results figures for that outcome appear in the data as lodged. This means it is not possible to describe what the scans showed or what conclusions, if any, were drawn from the numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01262560 · results posted 31 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people in total across three groups: 53 received standard supportive care, 54 received liquid Manuka honey, and 56 received Manuka honey lozenges. Nearly all participants completed the trial — only one person in the liquid honey group and two in the lozenge group did not finish. The trial was looking at whether Manuka honey, taken in two different forms, had any effect on throat pain caused by radiation treatment, as well as swallowing difficulty, quality of life, and weight changes. The reported data shows that for the main outcome — change in pain on swallowing at four weeks, measured on an 11-point scale (where 0 means no pain and 10 means the worst pain imaginable) — all three groups reported a change of 1 point. For swallowing difficulty, tracked through a daily diary using a 1–5 scale, scores were similar across the groups at most time points, though at the latest recorded time point the liquid honey group reported a score of 2 and the lozenge group 1.86, compared to 1.36 for the supportive care group. For quality of life, scores were broadly similar across groups at both four and twelve weeks. Regarding severe throat inflammation (graded as "severe" or higher on a standard medical scale), the reported data shows 12.5% of the supportive care group, 2.0% of the liquid honey group, and 6.0% of the lozenge group reached that level. For weight change at four weeks, the supportive care group reported an average loss of about 2.22% of body weight, the liquid honey group about 0.62%, and the lozenge group about 2.64%. It is worth noting that for several of the secondary outcomes, the numbers reported appear to represent starting (baseline) values rather than changes over time, and some detail about timing and statistical comparisons was not fully reported in the submitted data, so a complete picture of all findings is not 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.
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NCT01231399 · results posted 31 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom completed the study. Every participant received the same daily dose of 2.5 mg of a medicine called everolimus. The trial was measuring several things: the highest dose that could be given without too many participants experiencing serious side effects (called the Maximum Tolerated Dose), how many participants' tumours responded to treatment, how long participants went without their disease getting worse (progression-free survival), and how long participants survived overall. The reported data shows that the dose of 2.5 mg per day was recorded as the Maximum Tolerated Dose — meaning it was the dose tested where fewer than one in three participants experienced a serious attributable side effect. Out of the 6 participants, 5 were reported as having an overall tumour response, which in this trial meant their tumours either disappeared completely or shrank by at least 30% as measured by scans. The reported data also shows that, on average, participants went approximately 14.5 months before their disease was recorded as progressing or worsening. The reported overall survival figure — meaning the estimated average time from starting treatment until death from any cause — was approximately 20.3 months. It is worth noting that this was a very small trial with only 6 participants, so the numbers above reflect a limited group of people and should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00795184 · results posted 3 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 122 people in total — 65 in one group and 57 in another — who had a condition called Barrett's oesophagus, where the lining of the food pipe changes in a way that can sometimes develop into cancer. The trial was comparing different camera-based techniques used during an endoscopy (a procedure where a thin flexible tube with a camera is passed into the stomach) to see how well each technique could spot areas of serious abnormal cell change (called high-grade dysplasia) or very early cancer. The techniques compared included standard high-definition white light endoscopy (HDWLE), narrow band imaging (NBI, which uses different coloured light to highlight tissue), and a specialised microscopic imaging tool called probe-based confocal laser endomicroscopy (pCLE, which gives a close-up, microscopic view of the lining). Not all participants completed the study — 57 finished in the first group and 44 in the second. The reported data shows results for two measures: "sensitivity" (how often a technique correctly spotted a real abnormal lesion, out of all the abnormal lesions present) and "specificity" (how often a technique correctly identified a normal area as normal, out of all the normal areas). For sensitivity, the reported figures were: HDWLE alone 34.2%, NBI alone 41.7%, pCLE alone 62.5%, all three combined 75.8%, HDWLE plus pCLE 68.3%, and HDWLE plus NBI 45.0% — all expressed as a percentage of lesions. For specificity, the reported figures were: HDWLE alone 92.7%, NBI alone 90.5%, pCLE alone 92.7%, all three combined 84.2%, HDWLE plus pCLE 87.8%, and HDWLE plus NBI 88.2%. These numbers describe what was measured and recorded during this trial for these particular participants. No data on reasons for not completing the study was reported in the structured 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 ↗
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NCT01032044 · results posted 22 April 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01032044) looked at a condition called Barrett's oesophagus, which involves changes to the lining of the food pipe. The trial compared two approaches to guiding treatment: a standard endoscopic evaluation (using a camera to look inside the food pipe in the usual way) versus a newer technique called pCLE-guided evaluation (which uses a tiny microscope during the procedure to look at tissue in more detail). A total of 164 people were enrolled — 82 in each group — though not all participants completed the study: 57 in the standard group and 62 in the pCLE group finished. The reported data shows that the trial's main measure was the number of participants in each group who were classed as "optimally treated." This was defined as people where all abnormal tissue was removed when disease was present, no unnecessary treatment was given when disease was absent, or where complete removal of all disease was confirmed at a three-month follow-up check. According to the results reported on ClinicalTrials.gov, 16 participants in the standard treatment group and 16 participants in the pCLE-guided group met this "optimally treated" outcome. No other outcome measures were included in the submitted results data. It is worth noting that the data provided does not include information on any secondary outcomes, side effects, or other measurements — those figures 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 ↗
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NCT01093755 · results posted 17 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 16 in the dexlansoprazole group and 14 in the omeprazole group. Both are medicines commonly used to reduce stomach acid. The trial was measuring changes in two biological markers found in tissue samples taken from the oesophagus (the tube connecting the mouth to the stomach). These markers — called PGE2 and COX-2 — are associated with inflammation, and the trial tracked whether they changed after treatment compared to where they started (this is referred to as "change from baseline"). By the end of the study, 13 people in the dexlansoprazole group and 10 in the omeprazole group had completed the trial. The reported data shows the following numbers for the two markers. For PGE2 (measured in nanograms per gram of tissue), the dexlansoprazole group had reported values of +1.35 and +1.19, while the omeprazole group had values of −0.02 and −0.06 — meaning the dexlansoprazole group's readings went up slightly from their starting point, and the omeprazole group's readings stayed very close to where they began. For COX-2 (measured as a percentage of a reference protein called tubulin), the dexlansoprazole group had reported values of 36.81 and 56.54, while the omeprazole group had values of 27.17 and 25.49. The reported data does not provide enough context to explain why two separate figures appear for each group, and no further breakdown was included in the submitted results. It is worth noting that these numbers describe changes in laboratory measurements from tissue samples — they are not a direct measure of how patients felt or what symptoms they experienced. No symptom or quality-of-life outcome data was included in the results submitted to ClinicalTrials.gov for this 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.
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NCT00390416 · results posted 14 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 48 participants, all of whom received a combination of five medicines: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, and Leucovorin. Of those 48 people, 44 completed the study and 4 did not. The trial was measuring two main things: how many participants were still alive and had not seen their disease get worse after six months, and overall survival at one year. A secondary measure looked at how many participants with detectable disease showed a response to treatment. The reported data shows that 79% of participants were free from disease progression (meaning their disease had not worsened or they had not died) at the six-month mark. For the one-year survival outcome, the data reports two figures — 12 months and 16.8 months — though the trial record does not clearly label what each of these two numbers separately represents, so it is not possible to describe them more precisely without risking misrepresentation. For the secondary outcome looking at confirmed response rate among participants with measurable disease, the reported data shows two figures: 67% and 85%. Again, the record does not clearly distinguish what each figure refers to individually, so only the numbers as submitted can be noted 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.
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NCT00177255 · results posted 8 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people, all of whom were treated with a combination of two medicines called docetaxel and capecitabine. All 39 participants completed the study. The trial was measuring two main things: how long participants lived after starting treatment (called overall survival), and how many participants' cancer showed a measurable reduction in size (called the overall response rate). The reported data shows that the average length of time participants lived after starting treatment was 10.7 months. For the response rate, the reported data shows that 28.2% of participants — meaning roughly 11 out of the 39 people — had their cancer shrink to some degree (either completely or partially) while on the treatment combination. 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.
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NCT00397904 · results posted 25 November 2015
I notice the primary outcome measure contains four separate measurement values for the one group, which likely correspond to different response categories (such as complete response, partial response, stable disease, and progressive disease), but the data as submitted does not include labels for each of these categories. I will describe what is available without inventing labels. --- According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people, all of whom received a combination of three medicines: cetuximab, cisplatin, and irinotecan. All 16 participants completed the study. The trial was measuring how many people experienced a complete response (tumour fully disappearing) or a partial response (tumour shrinking by a meaningful amount) while on this treatment combination. The reported data shows four separate numbers for the one group — 0, 1, 4, and 11 participants — which appear to represent different categories of how participants' disease responded. However, because the submitted data does not include labels identifying which number belongs to which response category, it is not possible to state with certainty which figure represents complete responses, partial responses, or other outcomes. Describing them beyond those raw numbers would require guessing, which this summary will not do. Because the category labels were not reported in the structured data on ClinicalTrials.gov, a complete plain-English breakdown of the response results cannot be provided here. If you are looking for the full breakdown, speaking with a doctor or checking any published journal article associated with this trial may provide clearer detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00754468 · results posted 4 November 2015
According to the results reported on ClinicalTrials.gov, this trial involved a total of 7 people, split into two groups — 4 people in Group 1 and 3 people in Group 2. All 7 participants completed the study with no one dropping out. The trial was looking at a procedure called Cryo Spray Ablation, and it measured two things: how deep the treatment reached into tissue (measured in millimetres under a microscope), and what side effects were reported. The reported data shows that when tissue samples were examined under a microscope, the maximum depth the treatment reached was 4.0 millimetres in Group 1 and 5.2 millimetres in Group 2. For the secondary measure — side effects experienced by participants — the reported data shows that Group 1 had 2 side effects recorded, while Group 2 had 1 side effect recorded. No further detail about the nature of those side effects was included in the reported data. It is worth noting that this was a very small trial with only 7 participants in total, and the results data submitted does not include further breakdown of what those side effects were or any other detailed findings beyond the numbers 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 ↗
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NCT01097304 · results posted 15 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people, all of whom received the study treatment, ursodiol (also known as ursodeoxycholic acid, a type of bile acid tablet). Of those 36 participants, 29 completed the study and 7 did not. The trial was looking at several things in people with Barrett's oesophagus — a condition affecting the lining of the food pipe — including changes in a marker of DNA damage in cells, changes in the mix of bile acids found in the stomach, and changes in how quickly certain cells were multiplying. The reported data shows that the main thing being measured — a marker of oxidative DNA damage in cells, called 8OHdG, expressed as the percentage of cell nuclei showing a strong or moderate staining reaction — was reported as 1.62% for the treatment group. For the secondary measurements, the reported data shows that ursodeoxycholic acid and its related compounds made up 66.28% of total bile acids found in the stomach after the intervention period. Another type of bile acid, deoxycholic acid and its related compounds, changed by –13.31% of total bile acid (meaning it made up a smaller share after treatment). The reported data also shows a 1.36% change in cell multiplication activity, measured by a marker called Ki-67, in the affected tissue. It is important to note that the data as submitted does not include the before-and-after (baseline) figures separately, so the context for these numbers is limited to what 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.
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NCT01243619 · results posted 5 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants and all 5 completed the study. The trial was testing whether it was practical (described as "feasibility") to collect three sets of specialised medical scans — known as PET scans — from each participant at set points during their treatment, and then import and analyse all of those images together using a single advanced computer software program. Two types of PET scans were used: one called FDG-PET and another called FLT-PET, which are different methods of imaging the body's activity using small amounts of radioactive material. The reported data shows that all 5 participants successfully completed all three rounds of scanning at the required time points, and the scans were able to be imported into the software platform for analysis. This was the main thing the trial set out to measure — whether the process was workable — and the reported number indicates that it was carried out in all participants without any drop-outs. The trial also planned to look at how closely the two types of PET scans matched each other, and whether either type of scan corresponded with findings from surgery. However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for this part of the study, so those findings are not available 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.
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NCT00515216 · results posted 27 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people, all of whom received the same combination treatment: oxaliplatin, leucovorin, and 5-FU (a chemotherapy regimen). Twenty-five of the 26 participants completed the study. The trial was primarily measuring how many participants' tumours shrank or disappeared (called the "overall response rate"), and secondarily looking at how long participants lived overall, how long it took for the disease to get worse, and how many participants' disease was kept under control in some way. The reported data shows that 39.1% of participants met the definition of having their tumour shrink significantly or disappear entirely. For the secondary measurements, the reported data shows that the average length of time participants lived overall was 11.4 months, and the average length of time before the disease got worse was 6.2 months. The disease control rate — meaning the proportion of participants whose tumour either shrank or stayed stable rather than growing — was reported as 95.7%. For one secondary outcome looking at tumour-specific biological changes that might affect treatment outcomes, no numerical data was reported. A separate secondary measure looked at whether a particular gene variant was linked to tumour shrinkage; the reported data shows that among those with a partial tumour response, 5, 2, and 2 participants carried different versions of the gene in question, though further detail on what those categories represent was not 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 ↗ · Linked publication on PubMed ↗
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NCT00757172 · results posted 19 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people, all of whom received the same treatment combination: the drugs docetaxel, cisplatin, and panitumumab given together with radiation therapy. The trial was looking at how well this combination worked before surgery for what appears to be a cancer affecting the digestive tract, with the main goal being to measure how many participants showed no detectable cancer cells remaining when their surgical tissue was examined (called a "pathologic complete response"). Fifty-four participants completed the study, and eleven did not. The reported data shows that out of the 65 participants, 18 had no viable cancer cells found in their removed tissue after treatment — this was the key result the trial was designed to measure. An additional 11 participants showed a "near-complete response," meaning only a very small amount (10% or less) of living cancer remained in the tissue. For longer-term outcomes, the reported data shows that approximately 41.4% of participants were free from disease returning at the two-year mark, and approximately 38.6% were still alive at the three-year mark. Regarding serious side effects (rated as severe or life-threatening on a standard medical scale), the reported data shows that across several different categories of side effects, between 11 and 30 participants experienced events at that serious level, though the data as reported does not break down exactly which side effect each number refers to. 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 ↗
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NCT01447927 · results posted 21 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people with Barrett's oesophagus — a condition where the lining of the food pipe changes in a way that can sometimes lead to cancer. Thirty-eight participants were given metformin (a medicine commonly used for type 2 diabetes) and 36 were given a placebo (a dummy treatment with no active ingredient). The trial was measuring whether metformin had any effect on the activity of a specific protein called pS6K1, which can be detected in tissue samples from the food pipe and is thought to be involved in abnormal cell growth. Sixty-six participants completed the study. The reported data shows that after three months, the level of pS6K1 activity in the metformin group had changed by an average of +1.4% from where it started — meaning it was slightly higher than at the beginning. In the placebo group, the average change was -14.7%, meaning activity in that group was lower than at the start. These are the numbers as submitted; the trial did not report a statistical comparison figure in the data provided here. The reported data also shows that a number of participants experienced adverse events (unwanted effects, graded by a standard medical scale). Some adverse events were more commonly recorded in the metformin group, while others appeared in both groups or only in the placebo group — the exact breakdown by type of event was not fully detailed in the structured data provided. The trial noted only events that occurred three or more times across 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 ↗ · Linked publication on PubMed ↗
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NCT00522795 · results posted 22 August 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants, all of whom received the same treatment — a combination of a drug called PPX, cisplatin (a chemotherapy medicine), and radiation therapy. All 40 participants completed the study. The trial was measuring what is called a "complete pathologic response," which means that after surgery, pathologists (doctors who examine tissue under a microscope) looked to see whether any cancer cells could still be found in the removed tissue. The reported data shows that out of the 40 participants, 12 had a complete pathologic response — meaning that when their tissue was examined after surgery, no remaining cancer cells were detected. No other outcome measures, such as secondary outcomes covering things like survival rates or side effects, appear to have been submitted to ClinicalTrials.gov as part of this results entry, so those figures cannot be described 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.
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NCT00678535 · results posted 16 May 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00678535) enrolled 904 people with gastric (stomach) cancer — 455 in a group receiving cetuximab combined with two chemotherapy medicines (capecitabine and cisplatin), and 449 in a group receiving the two chemotherapy medicines alone. The trial's main goal was to measure how long it took for each person's cancer to first grow or spread after starting treatment — a timeframe called "progression-free survival." Researchers also tracked how long people lived overall, how many people's tumours shrank or disappeared, and participants' self-reported quality of life. The reported data shows that, for the main measure, the median time before the cancer progressed was 4.4 months in the cetuximab-plus-chemotherapy group and 5.6 months in the chemotherapy-alone group. (Median means half the participants reached that point sooner, and half took longer.) For overall survival, the reported median was 9.4 months in the cetuximab-plus-chemotherapy group and 10.7 months in the chemotherapy-alone group. The proportion of participants whose tumours showed the best response (shrank significantly or disappeared completely) was reported as approximately 29.9% in the cetuximab group and 29.2% in the chemotherapy-alone group. Quality-of-life scores, measured across several time points using two standard questionnaires, were broadly similar between the two groups throughout the study. Regarding side effects, 446 out of 455 participants in the cetuximab-plus-chemotherapy group and 432 out of 449 in the chemotherapy-alone group were reported to have experienced at least one adverse event (an unwanted medical occurrence during the study). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00109850 · results posted 23 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people, with 21 of them going on to receive treatment. 18 participants completed the study, while 4 did not finish. The trial was looking at a combination treatment — cetuximab, cisplatin, and irinotecan (three medicines given together), followed by radiation therapy — for people with a particular type of cancer. The main thing the trial was measuring was how many participants were still alive two years after joining the study. The reported data shows that 33.3% of participants (roughly one in three) were still alive at the two-year mark. For a secondary measure looking at how tumours responded to treatment, 17.6% of participants showed a recorded response — meaning their cancer either disappeared or shrank by a meaningful amount according to the study's definitions. The reported data also shows that the average time before the disease progressed (got worse or caused new symptoms) was 6.4 months. Separately, the trial tracked serious side effects (rated as severe, life-threatening, or fatal) that were considered related to the study drugs; the reported data shows varying numbers of participants experienced different types of these events, with figures ranging from 1 to 5 participants per event type, though the specific labels for each event type were not included in the data provided to ClinicalTrials.gov in a way that can be matched 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.
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NCT00096031 · results posted 1 May 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 participants, all of whom received a treatment called cetuximab. Of those, 57 were confirmed as eligible and 55 went on to begin the planned treatment. The trial was a single-group study — meaning there was no comparison group — and it was primarily measuring how many participants were still alive at six months after joining the trial. It also tracked two other time-based measures: how long it took for treatment to "fail" (meaning the disease got worse, the person passed away, their health declined significantly, or they stopped treatment early), and how long it took for the disease itself to progress. The reported data shows that 36% of participants were alive at the six-month mark. For the two secondary measures, the reported data shows a median of 1.8 months for both "time to treatment failure" and "time to progression." The word "median" here means the middle value — half of participants reached that point sooner than 1.8 months, and half took longer. No data was reported for the number of participants who formally "completed" the study, as this was recorded as zero, which is consistent with a study design where participants are followed until an event (such as disease progression or death) occurs rather than a fixed end point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00086996 · results posted 3 April 2012
According to the results reported on ClinicalTrials.gov, 98 people enrolled in this trial, which tested a treatment approach combining chemotherapy, radiation therapy, and surgery for a single group of participants. Of those who enrolled, 93 were confirmed eligible and began the planned treatment. The trial was primarily looking at whether participants showed a "pathological complete response" after the chemotherapy, radiation, and surgery phase — meaning no sign of disease could be found when tissue was examined under a microscope after surgery. The trial also tracked how long participants lived overall, how long they went without their disease getting worse, and what serious side effects occurred. The reported data shows that out of the 93 eligible participants, 26 were recorded as having a pathological complete response — that is, no detectable disease remaining in the tissue examined after surgery. For overall survival, the reported median figure (the midpoint value — meaning half of participants had results above this and half below) was 28.3 months from the time they registered for the trial. For progression-free survival — the time until the disease was first recorded as getting worse, or until death — the reported median was 19.7 months. Regarding serious side effects considered possibly, probably, or definitely related to the study treatment, the reported data shows varying numbers of participants experienced different grade 3 to 5 adverse events (meaning moderate-to-severe or life-threatening reactions), with individual event counts ranging from 1 to 15 participants across multiple categories. 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 ↗
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NCT00815308 · results posted 3 February 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 people, all of whom received a combination of the drug cetuximab alongside chemotherapy and radiotherapy given at the same time. The trial was measuring how well this combination reduced or eliminated tumours (the "response rate"), as well as tracking side effects, survival over time, and a specific gene change (called a K-ras mutation) in tumour samples. Of the 55 people who started, 45 completed the trial and 10 did not. The reported data shows that out of 55 participants, 44 were recorded as having an overall response — meaning their tumour either disappeared completely or shrank by at least 30% based on scans and other tests carried out 3–6 weeks after treatment finished. For side effects, the reported data shows that all 55 participants experienced at least one adverse event of some kind, which were tracked and graded using a standard medical scale. Regarding the K-ras gene mutation (a change in a gene that can affect how certain cancers behave), results were reported for 53 participants. For the remaining secondary outcomes — survival at one year, survival at three years, and the length of time before the disease progressed — the data was not reported in the ClinicalTrials.gov submission. 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 ↗
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NCT00423150 · results posted 5 July 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 86 participants, all of whom received a treatment called temozolomide. The trial was measuring how tumours responded to this treatment, specifically looking at whether tumours disappeared completely or shrank by at least 30% in size. The data shows that none of the 86 participants were recorded as having completed the study in the traditional sense — all 86 were listed under "not completed," though this does not necessarily mean they dropped out, as this can reflect how the study was structured or recorded. The reported data shows that the main thing being measured was tumour response, assessed using a standard set of criteria called RECIST (a widely used system for measuring whether tumours grow, shrink, or stay the same). According to the results reported on ClinicalTrials.gov, zero participants had a complete response — meaning no participants had all signs of their tumour disappear entirely. Five participants were reported as having a partial response — meaning their tumours shrank by at least 30%. No other outcome measures, such as secondary outcomes, appear to have been reported in the submitted data. It is worth noting that the data submitted to ClinicalTrials.gov for this trial is limited, and a number of details — such as how long participants were followed, or any other measurements that may have been taken — 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 ↗
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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.