Reported trial results for Head and Neck Cancer
Every Head and Neck 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.
49 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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NCT05909904 · results posted 14 July 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people in total, split evenly into four groups of 40. Each group received a different combination of three investigational medicines — tislelizumab, surzebiclimab, and alcestobart — to test them alone and in various combinations. The trial was measuring how tumours responded to these treatments in people with solid cancers, using standard imaging-based criteria to track whether tumours shrank, stayed stable, or grew. The reported data shows that the main outcome — the proportion of participants whose tumours shrank by a meaningful amount (called the objective response rate) — was very similar across all four groups: 27.5% for tislelizumab alone, 27.5% for tislelizumab plus surzebiclimab, 25.0% for tislelizumab plus alcestobart, and 27.5% for the three-drug combination. For the secondary outcomes, the length of time before the disease worsened (progression-free survival) ranged from 2.6 months in the tislelizumab-alone group to 5.4 months in the tislelizumab plus surzebiclimab group. The proportion of participants who experienced any treatment-emergent adverse event (an unwanted sign or symptom recorded during the study) ranged from 34 to 40 out of 40 participants across the groups. Duration of response — how long a tumour response lasted — was reported as 8.2 months for the tislelizumab-alone group; this figure was not reported for the other three 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.
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NCT03780725 · results posted 13 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03780725) involved two small groups of participants receiving a combination of two experimental medicines — ezabenlimab and BI 754111. Part 1 included 3 participants who received the higher dose of BI 754111 (600mg), and Part 2 included 5 participants who received a lower dose of BI 754111 (40mg), both combined with the same dose of ezabenlimab (240mg). The trial was measuring how well a specially labelled (radioactive) version of BI 754111 could be detected accumulating in tumours using medical imaging scans, taken at two time points after dosing — at 96 hours and 144 hours. No participants completed the study as defined by the trial protocol. The reported data shows the main measurement used was called "SUVpeak" — a unitless number that reflects how much of the radioactive tracer was detected concentrating in tumour tissue relative to the rest of the body; a higher number means more of the tracer was detected in the tumour area. In Part 1 (higher dose group), the reported SUVpeak values across the two imaging time points and two treatment cycles were 5.5, 5.2, 6.2, and 7.0. In Part 2 (lower dose group), the reported values were 5.8, 4.6, 4.9, and 4.3. The data does not include further breakdown or additional outcome measures beyond these imaging measurements, so no other findings are available to report. 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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NCT04854499 · results posted 19 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04854499) enrolled a total of 193 people across six groups. It tested combinations of a drug called magrolimab (alongside other cancer medicines) in people with a type of head and neck or gastric cancer. The trial had two phases: a smaller safety "run-in" phase to check for serious early side effects, followed by a larger Phase 2 portion that looked at how well tumours responded to treatment and how long participants went without their disease getting worse. The reported data shows that in the safety run-in groups, 0% of participants in either the magrolimab-pembrolizumab-chemotherapy group or the magrolimab-docetaxel group experienced what the trial defined as a "dose-limiting toxicity" — that is, a severe side effect judged to be caused specifically by magrolimab rather than the other medicines. However, serious abnormal laboratory results (Grade 3 or 4, meaning notably outside the normal range) were reported in 83.3% of participants in the first run-in group and 71.4% in the second. In the main Phase 2 comparison (Arm A vs Arm B), the reported median time before disease progressed or death occurred was 5.5 months for the magrolimab combination group and 5.6 months for the comparison group — these figures represent the midpoint of a time-to-event estimate across participants. In the magrolimab-plus-docetaxel group (Cohort 3), 12.2% of participants were reported to have had their tumour shrink meaningfully (a "complete" or "partial" response by standard measurement criteria). The reported data also shows that a small percentage of participants — ranging from 0% to 16.7% depending on the group — developed antibodies against magrolimab itself during the trial. Blood level measurements of magrolimab were also recorded across groups, though a detailed breakdown of all those figures was not fully separable from 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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NCT03076255 · results posted 15 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03076255) enrolled 12 participants, and all 12 completed the study — none dropped out. The trial was testing a device called a Maskless Immobilization Device (MID), which is a type of support used to keep a patient's head and neck still during radiation treatment planning. The study was measuring how precisely and consistently the device could position participants, compared to the traditional method of using a custom-fitted thermoplastic mask (a firm plastic mould made to fit a patient's face). The reported data shows that accuracy was measured by looking at small positional differences — called "translational shifts" — between where a participant was positioned on each treatment day versus where they were positioned during the original planning scan. These shifts were measured in centimetres. The three shift values reported for the group were 0.08 cm, 0.16 cm, and −0.02 cm. A negative number here simply means the position moved in the opposite direction compared to the reference point. It is worth noting that the data as submitted does not clarify exactly which directions of movement these three figures represent, so a full breakdown was not reported in a way that can be described further 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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NCT03552965 · results posted 30 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03552965) enrolled 23 people in total — 10 in the "Margin-Based Radiotherapy Planning" group and 13 in the "Robust Radiotherapy Planning" group. The trial was comparing two different technical approaches to planning radiotherapy treatment, and it was measuring dry mouth (also called xerostomia) as its main outcome. Dry mouth is a common side effect of radiotherapy to the head and neck area. Thirteen participants completed the study (5 in the margin-based group and 8 in the robust planning group), while 10 did not complete it. The reported data shows that dry mouth was measured in two ways. The first was a self-reported scale called LENT/SOMA, which runs from Stage 1 ("occasional dryness") to Stage 4 ("complete dryness, debilitating") — so lower numbers mean less severe dry mouth. This was measured at multiple time points. The reported average scores for the margin-based group across those time points were approximately 1.14, 2.00, 2.50, 1.83, and 2.00, while the robust planning group recorded approximately 1.17, 2.91, 2.33, 2.33, and 2.38. The second measure was the Xerostomia Questionnaire (XQ), a score out of 80 where higher numbers indicate worse dry mouth. The reported data shows average scores of 15.5 (margin-based group) and 14.1 (robust planning group) on this questionnaire. The data does not specify which time points these questionnaire scores relate 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.
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NCT05323656 · results posted 9 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05323656) enrolled 55 people in total — 27 in a group receiving setanaxib (1600 mg) combined with pembrolizumab (200 mg), and 28 in a group receiving a placebo combined with pembrolizumab. The trial was looking at how tumours responded to these treatments in terms of size changes, how long it took for the disease to progress, and changes in certain cells found in tumour tissue. Only 1 participant in each group completed the study, with the large majority not completing it. The reported data shows that for the primary measure — the best reduction in tumour size recorded during the trial — the setanaxib plus pembrolizumab group had an average reduction of about 7.9%, while the placebo plus pembrolizumab group had an average reduction of about 12.9%. For the secondary measure of progression-free survival (the length of time before the disease worsened or a participant died), the reported median was 151 days in the setanaxib group and 87 days in the placebo group. Regarding overall response rate (the number of participants whose tumour shrank to a meaningful degree), the reported data shows 1 participant had a complete response and 8 had a partial response in the setanaxib group, compared with 0 complete responses and 9 partial responses in the placebo group. The trial also measured changes in specific cell types within tumour tissue (including cancer-associated fibroblasts and immune cells), with various figures reported at baseline and follow-up for both groups, though a full breakdown of the differences 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.
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NCT03452137 · results posted 9 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03452137) enrolled 406 people in total — 203 in a placebo group and 203 in a group receiving a medicine called atezolizumab. All participants had been treated for a type of head and neck cancer (squamous cell carcinoma of the head and neck). The trial was mainly measuring "event-free survival" — that is, how long people went without their cancer coming back, spreading, or progressing, or without dying. This was tracked from the point each person was randomly assigned to their group. The reported data shows that the median event-free survival (the point in time by which half the group had experienced a setback) was approximately 52.7 months in the placebo group and approximately 59.5 months in the atezolizumab group. Looking at the proportion of people who remained event-free over time, the reported figures were broadly similar between the two groups: for example, at the 4-year mark, approximately 55% of the placebo group and approximately 55% of the atezolizumab group were still event-free (based on independent review). For overall survival — how long people lived regardless of whether their cancer progressed — the median figure was not yet reached at the time of reporting, meaning not enough deaths had occurred in either group to calculate that number. At 2 years, approximately 79% of the placebo group and 82% of the atezolizumab group were still alive; at 5 years those figures were approximately 62% and 61% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04905134 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 53 participants who each underwent two examinations of the upper airway and throat — one using a standard camera scope (called a nasopharyngoscope, a thin flexible tube passed through the nose to look at the throat) and one using a new prototype version of the same type of device. Three participants did not complete the first examination, so 50 participants went on to complete both exams. The trial was measuring how easy the new prototype scope was for providers to use, how good the image quality was from each device, and how participants felt during the procedure. The reported data shows that, out of 50 exams using the prototype scope, providers rated it as "very easy" to use in 2 exams, "easier" in 6, "the same" in 33, "harder" in 9, and "very hard" in none. For image quality, the standard scope was rated "very good" in 14 exams and "excellent" in 36, with none rated lower. The prototype scope was rated "good" in 2 exams, "very good" in 13, and "excellent" in 35. When providers were asked whether participants experienced more, the same, or less pain or discomfort with the prototype compared to the standard scope, 6 participants were reported as having more discomfort, 29 about the same, and 15 less. The reported data also shows that zero participants experienced an adverse event (an unexpected or unwanted medical occurrence) following use of the prototype scope. 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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NCT02777385 · results posted 1 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people with cancer who were split into two groups. Forty-one participants received pembrolizumab (an immunotherapy drug) at the same time as their standard treatment of cisplatin (a chemotherapy) and radiation — this is called the "concurrent" group. The other 39 participants received the same standard treatment first, with pembrolizumab added afterwards in a "sequential" approach. The trial was primarily measuring how many participants went a certain length of time without their disease getting worse (called progression-free survival), as well as how often the cancer came back in or near its original location (locoregional failure), and how many participants experienced serious treatment side effects. The reported data shows that, looking at progression-free survival (the proportion of people whose disease had not progressed), the numbers differed between the two groups at each time point measured. At 12 months, 71% of the concurrent group and 83% of the sequential group had not had disease progression. At 36 months, those figures were 57% and 75% respectively, and at 48 months, 49% and 67%. For cancer returning in or near its original site, the reported rate within one year was 15% in the concurrent group and 4% in the sequential group; within three years those figures were 26% and 4%. Regarding serious side effects (called dose-limiting toxicities — meaning side effects severe enough to affect the treatment plan), 3 participants in the concurrent group and 0 in the sequential group were reported to have experienced these. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03719690 · results posted 21 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03719690) involved two groups of participants with head and neck cancer. Fifty-nine people received the study drug tipifarnib (the treatment group, called AIM-HN), and 237 people were enrolled in a separate observational group (SEQ-HN) who did not receive tipifarnib and were followed for comparison purposes only. The trial was primarily measuring what proportion of participants in the tipifarnib group showed a measurable shrinkage in their tumours, and it focused particularly on patients whose tumours had a high level of a specific genetic change (called high VAF, or high "variant allele frequency" — meaning a larger proportion of the tumour's DNA carried a particular mutation). The reported data shows that in the tipifarnib group, among those with the high VAF genetic characteristic, 20.0% of participants had their tumours shrink enough to meet the trial's definition of a response (either the tumour disappearing completely or shrinking by at least 30%). When looking at all tipifarnib participants regardless of VAF level, the reported response rate was 18.6%. For those who did show a response, the reported data shows the median duration of that response — that is, the midpoint time before the cancer started growing again or the person passed away — was 6.51 months in both the high VAF group and the overall group. The reported median time from starting treatment until the cancer progressed or death occurred (called progression-free survival) was 2.60 months in the high VAF group and 2.23 months across all tipifarnib 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.
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NCT04217057 · results posted 28 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, and all 11 completed the study with no one dropping out. The trial was testing a specialised imaging scan called 64Cu-DOTA-ECL1i-PET/CT — a type of body scan that uses a small amount of radioactive material designed to highlight certain immune cells (known as CCR2-expressing cells) in the body. The study was measuring whether the scan produced images good enough to be useful for diagnosis, and whether it could detect those immune cells at sites of known disease. The reported data shows that when researchers rated the image quality on a four-point scale (where 1 is poor and 4 is good), all 11 participants received the top score of 4, meaning the images were rated as good quality and similar to routine clinical scans. For the second primary measure, the reported data shows that in all 11 participants, the scan picked up abnormal activity at the site of disease that had already been confirmed through other means; zero participants showed no such activity detected. Separately, tissue samples from participants were also analysed under a microscope to look at the presence of the CCR2 target directly in the tissue — the reported data shows that none of the participants had an absent signal, 2 had a weak signal, 5 had a moderate signal, and 3 had a strong signal, though the results for one participant were not reported in this category (the figures account for only 10 of the 11 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.
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NCT04634825 · results posted 20 December 2023
According to the results reported on ClinicalTrials.gov, this trial looked at two different drug combinations in people with cancer. One group of 48 participants received a combination of two drugs called enoblituzumab and retifanlimab, while a second group of 14 participants received enoblituzumab combined with a different drug called tebotelimab. The trial measured how many people's tumours shrank or disappeared (called the overall response rate), how many people experienced unwanted side effects (adverse events), and how long it took for the disease to get worse or for people to stay stable. Notably, the reported data shows that zero participants in either group were recorded as having formally "completed" the study, with all participants listed under "not completed" — though no further explanation for this is provided in the submitted data. The reported data shows that in the retifanlimab group, 3 out of 48 participants had their tumours shrink or disappear by the measures used in the trial. In the tebotelimab group, 2 out of 14 participants had the same result. For a broader measure called disease control rate — which also counted people whose disease stayed stable for at least three months — 19 participants were recorded in the retifanlimab group and 5 in the tebotelimab group. Regarding adverse events (unwanted side effects) in the tebotelimab group, 12 out of 14 participants were reported as having experienced them; the equivalent figure for the retifanlimab group was not reported in the submitted data. Two other measures — how long any response lasted and how long before the disease progressed — were listed as "not available" in the submitted data, meaning those figures were not 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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NCT04154943 · results posted 8 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04154943) enrolled 79 participants, all of whom received cemiplimab (350 mg every three weeks) before surgery — a treatment approach sometimes called "neoadjuvant" therapy, meaning it is given ahead of an operation. The trial was primarily measuring how many participants showed a "pathologic complete response" (pCR), which means that when surgeons and pathologists examined the tissue removed during surgery, no living cancer cells could be found. The reported data shows that out of 79 participants, 40 had a pathologic complete response when assessed by an independent central pathology review, and 42 when assessed by local pathology reviewers. Additionally, 10 participants in each review method had what is called a "major pathologic response" (mPR) — meaning only a very small amount of cancer cells remained in the removed tissue, though not zero. Before surgery, 68.4% of participants showed an "objective response," meaning their tumour appeared to shrink or reduce when assessed using standard imaging measurements (a scoring system called RECIST 1.1). Regarding surgery itself, the reported data shows that 77 participants had surgery planned and 68 actually went on to have it; 2 participants had surgery planned through a different pathway and 2 had it. The data reported shows that none of the 79 participants were recorded as having "completed" the study in the formal sense, with all 79 listed as "not completed" — no further explanation for this was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04428333 · results posted 25 May 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 117 people in total — 57 in one group and 60 in the other. Participants had cancer and were randomly assigned to receive one of two treatment combinations: one group received feladilimab together with pembrolizumab and a standard chemotherapy regimen (5-FU-platinum), while the other group received a placebo together with the same pembrolizumab and chemotherapy combination. The trial was primarily measuring how long participants lived overall (called "overall survival"), and how long they lived without their cancer getting worse (called "progression-free survival" — meaning the time from the start of the study until the disease progressed or the person passed away, whichever came first). The reported data shows that for the two main overall survival outcomes, the median figures were listed as "NA" (not available), meaning those particular results were not reported in the submitted data. For progression-free survival, the reported median time without disease worsening was 5.5 months in the feladilimab combination group and 4.7 months in the placebo combination group — both in the main study population and in a subgroup of participants whose tumours had a particular protein marker (PD-L1 positive). The reported data also shows that survival rates at 12, 24, and 36 months were noted as "not evaluated" and no figures were provided for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04128696 · results posted 24 May 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 315 people in total — 158 in the group receiving both feladilimab and pembrolizumab, and 157 in the group receiving a placebo alongside pembrolizumab. The trial was measuring two main things: how long participants lived overall (called "overall survival"), and how long they lived without their disease getting worse (called "progression-free survival"). These measurements were looked at in two subgroups — participants whose tumours showed a certain protein marker (PD-L1) at a moderate level or higher, and those whose tumours showed that marker at a high level. The reported data shows that, for overall survival in the moderate-or-higher protein marker group, the median time (meaning the point at which half the group had died and half had not) was 44.1 weeks for the feladilimab-plus-pembrolizumab group. For the placebo-plus-pembrolizumab group, a median figure was not able to be calculated from the data and was reported as "not available." In the high protein marker group, the median overall survival was 42.1 weeks in the feladilimab group, with the placebo group's figure again not reported. For progression-free survival in the moderate-or-higher marker group, the reported median was 10.1 weeks in the feladilimab group and 16.0 weeks in the placebo group. The reported data for the secondary outcomes shows similar patterns across different ways of measuring progression-free survival. In the moderate-or-higher marker group, using a slightly different measurement approach, the median was 13.0 weeks (feladilimab group) versus 21.4 weeks (placebo group). In the high marker group, progression-free survival medians ranged from 13.0 to 13.1 weeks in the feladilimab group, compared to 21.1 to 26.7 weeks in the placebo group, depending on the measurement method used. 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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NCT02741570 · results posted 3 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02741570) enrolled 472 people in the nivolumab plus ipilimumab group and 475 people in the EXTREME regimen group (a standard chemotherapy-based combination), for a total of 947 participants. The trial was measuring overall survival — that is, how long people lived after being randomly assigned to one of the two treatments — as its main goal. It looked at this both across all participants and within a subgroup whose tumours showed higher levels of a particular protein marker called PD-L1 (measured by a "combined positive score", or CPS, of 20 or above). The reported data shows that, among participants with a high PD-L1 marker level (CPS ≥ 20), the median overall survival — the point at which half the group had died and half were still alive — was reported as 17.58 months for the nivolumab plus ipilimumab group and 14.59 months for the EXTREME regimen group. Across all randomised participants, the reported median overall survival was 13.90 months versus 13.50 months respectively. For a subgroup with a lower PD-L1 threshold (CPS ≥ 1), the reported figures were 15.67 months versus 13.24 months. The reported data also shows that the proportion of participants whose tumours shrank by a meaningful amount (called the objective response rate) was reported at varying figures across different subgroups — ranging from around 24% to 34% for the nivolumab plus ipilimumab group and around 35% to 37% for the EXTREME regimen group. Among those who did respond, the reported median duration of that response was notably longer in the nivolumab plus ipilimumab group (reported as approximately 16.6 to 33.5 months across subgroups) compared with the EXTREME regimen group (approximately 5.9 to 7.0 months). Progression-free survival — the time before tumours grew or a person died — was not reported consistently across all subgroups 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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NCT02682992 · results posted 13 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 participants, all of whom completed the study with no drop-outs. All participants received low level laser therapy (a type of light-based treatment applied to the mouth) while undergoing radiotherapy for head and neck cancer. The trial was measuring how often participants developed severe mouth sores — known as oral mucositis — during their radiation treatment, specifically in those who received a cumulative radiation dose of at least 5,000 cGy (a unit used to measure radiation). The reported data shows that 23% of participants developed severe mouth sores, measured using two different grading systems (the WHO grading scale and a separate system called CTCAE), both of which returned the same figure. Among the secondary outcomes — additional things the trial tracked — the data shows that when severe mouth sores did occur, they lasted an average of 24 days, and the average total radiation dose received at the point when severe sores appeared was 56 Gy (another unit of radiation measurement). The reported data shows that 36% of participants required a feeding tube to be placed during treatment. The time from the start of radiotherapy to when severe mouth sores first appeared was not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03682367 · results posted 9 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03682367) enrolled a total of 8 participants, split evenly into two groups of 4 — a control group and an intervention group. The trial was measuring differences in pain-related outcomes between the two groups, specifically looking at the amount of opioid pain medication used (measured in "morphine equivalent units," a standard way of comparing different pain medicines), self-reported pain scores on a 1-to-10 scale, and the occurrence of complications after surgery or related to pain medication use. The reported data shows that, of the 8 participants who started the trial, only 2 from the control group completed it, while none of the 4 participants in the intervention group completed the study. The remaining 6 participants — 2 from the control group and all 4 from the intervention group — did not complete the trial. Importantly, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures, including opioid medication use, pain scores, or complication rates. The data for all primary and secondary outcomes was not reported. Because no outcome data was provided in the results submitted to ClinicalTrials.gov, it is not possible to describe what the trial found regarding any of its measurements. The very small number of participants and the high rate of non-completion in both groups are also worth noting as context for the absence of reported findings. 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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NCT02130427 · results posted 1 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02130427) enrolled 74 participants in a single group called the "Imaging" group. The trial was designed to measure how a tumour's size, movement, and the surrounding body area changed during a type of radiation treatment called photon beam radiotherapy. To track these changes, the study used specialised medical scans — either 4D or 3D CT scans (detailed X-ray images that can capture movement) and/or a series of MRI scans (images that use magnetic fields rather than X-rays). The reported data shows that 44 of the 74 participants completed the study, while 30 did not complete it. The reasons for not completing were not reported in the data provided. The only outcome measure reported was tumour volume — that is, the size of the tumour measured in cubic centimetres (cm³). Among those who completed the imaging, the reported average tumour volume was 93.55 cm³. No other outcome measures, such as tumour movement or changes in patient anatomy, appear to have had results submitted to ClinicalTrials.gov at this time. It is worth noting that this trial was focused on imaging and measurement — tracking what happens to tumours during treatment — rather than comparing one treatment against another. The data reported here describes what was observed and recorded, not whether any particular treatment approach performed better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01403064 · results posted 11 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total across four groups. Participants were receiving radiation therapy for head and neck cancer and were being treated with either a placebo (an inactive substance) or one of two doses of an experimental drug called ALD518 — either 160 mg or 320 mg. The trial was primarily measuring how often participants experienced unwanted health events (called adverse events), serious adverse events, and notable changes in laboratory test results. It also measured how often participants developed a painful mouth condition called oral mucositis — soreness and ulcers in the mouth — at different points during their radiation treatment. The reported data shows that, when it came to any type of adverse event, 95.7% of placebo participants, 100% of those receiving ALD518 160 mg, and 100% of those receiving ALD518 320 mg experienced at least one such event. Serious adverse events were reported in 30.4% of the placebo group, 46.9% of the 160 mg group, and 38.1% of the 320 mg group. Regarding mouth ulcers (oral mucositis) at the key radiation dose point of 55 Gray (a measure of radiation received), the reported data shows that 79.2% of placebo participants, 100% of the randomised 160 mg group, and 77.3% of the 320 mg group had developed this condition by that stage. The trial also tracked mouth ulcers at earlier radiation doses; at 45 Gray, rates ranged from 75% to 90.9% across the 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT01716195 · results posted 26 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people, all of whom received a treatment approach called "response adapted chemoradiation" — meaning the radiation and chemotherapy plan was adjusted based on how each person's body was responding during treatment. Seventeen of the 18 participants completed the study, and one did not. The trial was measuring how many participants went two years without their disease getting worse (called "progression-free survival"), how many participants were still alive over the course of the study (called "overall survival"), and how many participants experienced unwanted side effects during treatment. The reported data shows that out of 18 participants, 17 reached the two-year mark without recorded evidence of their disease progressing or death — this was the main thing the trial was tracking. For overall survival, the reported data shows 16 out of 18 participants were recorded as surviving over the follow-up period. Regarding side effects, the reported data shows that all 17 participants who completed the chemoradiation phase experienced at least one adverse effect (an unwanted reaction) during treatment. The data does not include a breakdown of what types or how serious those side effects were, so that detail was not reported in the structured results. It is worth noting that this was a very small trial with only 18 participants, and the results reflect only this specific group of people under specific study conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02952586 · results posted 24 February 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02952586) enrolled 697 people with head and neck cancer — 350 in the group receiving avelumab (an immunotherapy drug) alongside standard chemotherapy and radiation treatment, and 347 in the group receiving a placebo alongside the same standard treatment. The trial was designed to measure how long participants went without their cancer getting worse (called progression-free survival), as well as a number of other outcomes including how long participants lived overall, how their tumours responded to treatment, and whether cancer spread to other parts of the body. The reported data shows that for the main outcome — progression-free survival — no numerical result was reported for either group (recorded as "NA" in the data). The same applies to overall survival, time to local cancer returning, and time to cancer spreading to distant parts of the body; none of these figures were provided in the submitted results. For the percentage of participants whose tumours shrank significantly (called the objective response rate), the reported data shows 74.0% in the avelumab group and 74.9% in the placebo group. One smaller secondary measure looked at participants who had surgery after treatment and showed no remaining cancer in the removed tissue; the reported data shows 0% in the avelumab group and 14.3% in the placebo group, though the data notes this applied only to those who had salvage surgery at the primary site — a small subset of 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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NCT02633540 · results posted 17 February 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02633540) enrolled 2 participants, both of whom completed the study. The trial involved a single group of people who received a type of targeted radiation treatment (called IMRT) for early-stage larynx (voice box) cancer. The study was designed to look at three things: how participants rated the impact of their voice on daily life, how satisfied they were with their swallowing, and how a clinician assessed their swallowing function — all measured at various points up to 24 months after finishing treatment. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the three outcome measures. This means that figures for voice quality (measured using a questionnaire called the Voice Handicap Index), patient-reported swallowing satisfaction (measured using a tool called the EAT-10), and the clinician's assessment of swallowing (carried out using a camera examination of the throat) were all not reported in the structured results data available on the registry. Given that only 2 participants were enrolled and no outcome numbers were provided, the reported data does not allow any conclusions to be drawn about what the treatment may or may not do. 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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NCT03821064 · results posted 1 February 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03821064) tested a patient navigation programme called NDURE, which was designed to help people with head and neck cancer start their post-surgery radiation treatment on time. Eleven people enrolled in the study and ten completed it, with one person not finishing. The main thing the trial was measuring was how many participants had a delay in starting radiation — meaning it took more than six weeks (42 days) after surgery before radiation began. The reported data shows that out of the ten participants, 4 were recorded as having a delay in starting their post-surgery radiation treatment beyond that six-week mark. For one of the secondary measures — looking at any difference in delay rates between white participants and African American participants — a figure of 9.6 percentage points was reported. The reported median difference in the number of days from surgery to starting radiation between those two groups was zero days. The reported median time between surgery and the start of radiation for the group overall was 42 days (exactly at the six-week threshold). The reported data also shows that 3 participants had a radiation consultation before their surgery, and 6 participants had dental extractions completed on time before starting radiation. It is worth noting that this was a very small study, and the data was reported for a single group only, with no comparison group included. 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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NCT02163057 · results posted 23 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people in total — 6 in a surgery group (Cohort 1) and 16 in a chemoradiation group (Cohort 2). The trial was measuring the body's responses after receiving an investigational HPV-related treatment, specifically looking at two things: unwanted health events (called adverse events) that occurred during the study, and various markers in the blood that researchers used to track how the immune system — the body's defence system — was responding over time. The reported data shows that when it came to unwanted health events, all 6 participants in the surgery group and 15 out of 16 in the chemoradiation group experienced at least one treatment-emergent adverse event (that is, an unwanted health change that appeared or worsened after receiving the study treatment). Serious adverse events — defined as events that were life-threatening, caused hospitalisation, or led to significant disability — were reported in 2 participants in the surgery group and none in the chemoradiation group. For the immune response measurements, the reported data shows various blood markers — including antibody levels (proteins the immune system produces) and specialised immune cell counts — were tracked at multiple time points across both groups. The numbers for these markers generally showed changes from the starting point across both groups over the course of the study, though the specific values varied considerably between the two groups and across different time points. 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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NCT03255980 · results posted 16 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03255980) looked at a product called Xonrid, used alongside standard-of-care treatment, in people undergoing radiotherapy for either breast cancer or head and neck cancer. Each of the four groups started with 20 participants — giving 80 people in total across the trial. The trial was mainly measuring how many people avoided a moderate level of skin reaction (called Grade 2 radiodermatitis, a type of skin irritation caused by radiation) by the fifth week of treatment. A number of participants did not complete the study: in the breast cancer groups, 3 and 8 people respectively did not finish, and in the head and neck cancer groups, 6 and 12 people respectively did not finish. The reported data shows that at week 5, in the breast cancer part of the trial, 10 out of the Xonrid-plus-standard-care group and 5 out of the standard-care-only group had avoided reaching that moderate level of skin reaction. In the head and neck cancer part, 13 out of the Xonrid-plus-standard-care group and 11 out of the standard-care-only group had avoided it. These are the figures as submitted; the trial did not report the number of participants assessed in each group at that time point, so it is not possible to calculate exact proportions from the data provided. The reported data shows that results for all of the secondary outcome measures — including time to skin reaction, skin reaction at later time points, worst skin reaction during treatment, skin colour changes, and skin moisture loss — were not provided in the structured results submitted to ClinicalTrials.gov, 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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NCT03057613 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03057613) involved 18 participants who all completed the study. The trial was looking at a combination of a medicine called pembrolizumab given alongside post-operative radiotherapy (radiation treatment after surgery). The study had two main things it was measuring: first, whether certain serious side effects — called dose-limiting toxicities, meaning unwanted reactions severe enough to limit the treatment — occurred during or shortly after treatment; and second, how many participants went a period of time without their disease getting worse, known as progression-free survival. The reported data shows that out of the 18 participants, zero experienced a dose-limiting toxicity. This means none of the participants had a severe reaction that met the study's specific definition of a dose-limiting toxicity during the observation period. The reported data also shows that 17 out of 18 participants were recorded as having progression-free survival — meaning their disease had not progressed and they had not died from any cause at the time of their last follow-up. 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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NCT02608879 · results posted 28 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02608879) enrolled 19 people in total. Ten participants were placed in the OMDP (treatment) group, six in a control group, and three were not randomised into either group. The trial was measuring the severity of oral mucositis — a painful inflammation and ulceration of the mouth that can occur during cancer treatment — using two standard rating scales (the WHO scale and the NCI scale). It also looked at participants' pain levels and changes in the mix of bacteria found in the mouth. The reported data shows the following for mouth sore severity, scored at the end of the study period. Using the WHO scale (rated 0–4), in the OMDP group: 3 participants scored at level 1 (soreness with redness), none scored level 2, 6 scored level 3 (ulcers, liquid diet only), none scored level 4. In the control group: 3 scored level 1, none scored level 2, 2 scored level 3, none scored level 4, and 1 scored level 4 (unable to eat). Using the NCI scale (rated 1–5), in the OMDP group: 6 participants were at grade 1, 2 at grade 2, 1 at grade 3, and none at grades 4 or 5. In the control group: 3 were at grade 1, 1 at grade 2, 2 at grade 3, and none at grades 4 or 5. For pain (rated 0–10 using a faces picture scale), in the OMDP group the most common score was 2 ("hurts a little bit," reported by 6 participants), while in the control group 3 participants also scored 2. The reported data on mouth bacteria showed shifts in the proportions of different microbial species between the start of the study and when mouth sores appeared, though the specific species names were not included 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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NCT01976741 · results posted 28 April 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01976741) tested a drug called rogaratinib in people with advanced cancer, across several groups. A total of 168 participants were enrolled across all groups — including a dose-escalation phase (where six different twice-daily doses ranging from 50 mg to 800 mg were tested in small groups of 3–4 people each) and a dose-expansion phase (where larger groups of participants with specific cancer types, including bladder cancer, head and neck cancer, and a type of lung cancer, received the drug). The trial was primarily measuring how much of the drug reached the bloodstream at different doses, and whether any serious side effects occurred at a level that would make a dose too high to continue testing (called a "dose-limiting toxicity"). The reported data shows that during the first treatment cycle across all dose-escalation participants combined, zero dose-limiting toxicities were recorded, and the highest tested dose — 800 mg twice daily — was reported as the maximum tolerated dose (meaning it was the highest dose at which serious first-cycle side effects stayed below the pre-set 20% threshold). For the blood-level measurements, the reported data shows that the peak concentration of rogaratinib in the blood after a single dose on Day 1 rose with increasing doses — from around 3,640 µg/L (micrograms per litre) at the lowest 50 mg dose up to around 10,200–11,000 µg/L at the higher doses of 600–800 mg. Similarly, the total amount of drug in the blood over 12 hours (a measure called AUC) increased from roughly 12,100 µg·h/L at the lowest dose to around 55,700–74,200 µg·h/L at the highest escalation doses. A separate food-effect group receiving 100 mg showed notably higher blood levels compared with the standard fasted 100 mg group, though the data for that comparison was not broken down further in the submitted results. The reported data shows that across the expansion groups — which included participants with bladder cancer, head and neck cancer, and squamous non-small cell lung cancer — peak blood concentrations on Day 1 were generally in the range of approximately 10,900 to 13,900 µg/L, broadly consistent with the higher doses tested in the escalation phase. No secondary outcome measure results were included in the submitted data beyond what is described above, so further findings 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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NCT01111058 · results posted 7 April 2020
According to the results reported on ClinicalTrials.gov, this trial involved 52 people in total — 28 who received a medicine called everolimus (also known as RAD001) and 24 who received a placebo (a dummy treatment with no active ingredient). All 52 participants completed the study, with no drop-outs recorded. The trial was measuring how many people remained free from their disease getting worse over a two-year period, as well as tracking where in the body any worsening occurred, whether a second new tumour developed, and how many people experienced any unwanted side effects. The reported data shows that the two-year rate of remaining free from disease progression was very similar between the two groups — reported as 56.1% for the everolimus group and 55.9% for the placebo group. Regarding side effects of any kind and any severity, 25 out of 28 people in the everolimus group and 16 out of 24 people in the placebo group were reported to have experienced at least one. When looking at where disease progression occurred, 2 people in the everolimus group and 5 in the placebo group had progression in the local or nearby area; 2 people in each group had progression that had spread to other parts of the body; and 1 person in each group had a progression where the location was unknown. For the outcome measuring whether participants developed a second new tumour, no figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04137627 · results posted 9 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT04137627) enrolled 50 people in total — 25 in a group that received melatonin alongside chemotherapy, and 25 in a group that received a placebo (a dummy treatment) alongside chemotherapy. The trial was looking at patients receiving chemotherapy before surgery (known as neoadjuvant chemotherapy), and it set out to measure how their tumours responded to treatment, as well as changes in the levels of certain biological markers in the body. Not everyone finished the study: 13 people in the melatonin group and 12 in the placebo group completed it. The reported data shows that for the main outcome — how the tumour responded to chemotherapy, judged using a standard imaging-based scoring system called RECIST 1.1 — 5 participants in the melatonin group and 5 in the placebo group had a positive response (meaning their tumour shrank noticeably or disappeared). The remaining 8 in the melatonin group and 7 in the placebo group had a negative response (meaning their tumour stayed the same size or grew). For the secondary outcomes, the trial measured changes in the levels of four biological markers (HIF-1α, miR-210, CD44, and CD133) using a laboratory technique that detects tiny amounts of genetic material. The reported data shows that HIF-1α levels changed by −0.008 picograms/microliter in the melatonin group and +0.0027 in the placebo group; miR-210 changed by −109.09 in the melatonin group and −103.71 in the placebo group; CD44 changed by −0.0114 in the melatonin group and +0.0082 in the placebo group; and CD133 changed by +0.43 in the melatonin group and +0.55 in the placebo group. A negative number means the level went down from the start of the study to the end, and a positive number means it went up. It is worth noting that a large number of participants did not complete the trial (12 in the melatonin group and 13 in the placebo group), which the data does not explain further. 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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NCT00468169 · results posted 9 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people in total — 57 in one group (Group A, receiving cetuximab combined with a three-drug chemotherapy regimen called FHX) and 53 in another group (Group B, receiving cetuximab combined with a two-drug chemotherapy regimen called PX). Nearly all participants completed the study (56 out of 57 in Group A, and all 53 in Group B). The trial was measuring how long participants went without their cancer getting worse (called "progression-free survival"), as well as overall survival and how well tumours responded to treatment. The reported data shows that when looking at progression-free survival — that is, the estimated probability of a participant not having their disease worsen — at the one-year mark, 87.7% of Group A and 92.5% of Group B had not experienced progression. At two years, those figures were 82.5% for Group A and 84.9% for Group B. For overall survival at two years (the probability of still being alive), the reported data shows 91.2% for Group A and 94.3% for Group B. Regarding how tumours responded to the initial (induction) treatment phase, the reported data shows that in Group A, 7 participants had a complete response (cancer lesions disappearing entirely) and 47 had a partial response; in Group B, 4 had a complete response and 41 had a partial response. Residual disease after the combined chemotherapy and radiotherapy (CRT) phase was reported in 3 participants in Group A and 4 in Group B, while residual lymph node disease was found in 2 participants in Group A and 6 in Group B. 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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NCT02369874 · results posted 3 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02369874) enrolled 736 people across three groups: 247 received a combination of two immunotherapy medicines (durvalumab plus tremelimumab), 240 received durvalumab alone, and 249 received standard-of-care treatment. The trial was primarily measuring how long participants lived overall (called "overall survival"), and also looked at a number of other things including how long it took for the disease to worsen, how many participants' tumours shrank, and how long those responses lasted. The reported data shows that the median overall survival — meaning the point at which half the participants in each group had passed away — was 6.5 months for the combination group, 7.6 months for the durvalumab-alone group, and 8.3 months for the standard-of-care group. When looking only at participants whose tumours had lower levels of a particular protein (PD-L1 negative), the reported survival figures were 7.8, 7.6, and 8.0 months respectively. For participants with higher levels of that protein (PD-L1 positive), the figures were 4.8, 9.8, and 9.0 months. The reported data also shows that the time until the disease worsened or death occurred was 2.0 months for the combination group, 2.1 months for durvalumab alone, and 3.7 months for standard care. The proportion of participants whose tumours shrank was similar across all three groups — about 18.2%, 17.9%, and 17.3% respectively. Among those who did respond, the median length of that response was reported as 7.4 months for the combination group, 12.9 months for durvalumab alone, and 3.7 months for standard care. 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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NCT02369835 · results posted 17 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 132 people in total — 64 in the group using a Modified Dakin's Solution (a dilute antiseptic rinse) and 68 in the placebo group. The trial was looking at whether the solution made a difference to the severity of skin reactions (called radiation dermatitis) in people undergoing radiation treatment. Skin reactions were graded on a scale from A (no change) through to F (bleeding, ulceration, or infection), and the main question was how many people in each group developed a Grade E reaction — meaning moist desquamation, or skin that becomes wet and peels away. By the end of the study, 53 people in the Dakin's Solution group and 55 in the placebo group had completed the trial. The reported data shows that 34 out of 64 participants in the Modified Dakin's Solution group developed a Grade E skin reaction (or worse) during the study period, which runs up to 10 weeks after finishing radiation treatment. In the placebo group, 36 out of 68 participants reached that same level of skin reaction. For the secondary outcomes — how long it took for a Grade E reaction to develop, and pain levels measured using a questionnaire — the trial report on ClinicalTrials.gov states that no data was provided for either of these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02626000 · results posted 10 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people who all received a combination of two treatments: talimogene laherparepvec (an injected therapy) and pembrolizumab (an immunotherapy drug). Six participants were recorded as having completed the study, while 30 did not complete it. The trial was looking at how the two drugs behaved together — specifically, how many participants experienced a particular type of serious side effect (called a "dose-limiting toxicity," meaning a side effect severe enough that it might limit how much of the treatment could be given), and also how participants' tumours responded to the combination. The reported data shows that 1 out of 36 participants experienced a dose-limiting toxicity. For tumour response, the researchers tracked whether tumours shrank or disappeared. When looking at confirmed responses (where the result had to be verified by a follow-up scan at least four weeks later), 15.6% of participants showed either a complete disappearance or a meaningful shrinkage of their tumours. When using unconfirmed (first-recorded) results, that figure was 9.4%. No participants showed a complete disappearance of all tumours under either the confirmed or unconfirmed measure. Looking at individual confirmed responses across all 32 participants who could be evaluated: 3 had a meaningful partial shrinkage, 10 had stable disease (tumours neither grew nor shrank enough to count as a response), 4 had disease progression (tumours grew), 6 were listed as unevaluable, and 9 were recorded as "not done." The reported disease control rate — covering those with any shrinkage or stable disease — was 40.6%. The duration of confirmed responses was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02780765 · results posted 20 September 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 adults in total — 30 people in a "Heated Humidifier" group and 30 people in a "Mist Humidifier" group. All 60 participants completed the study with no drop-outs. The trial was looking at two things: how much a breathing tube (a tube placed in the airway to help someone breathe on a machine) became blocked or narrowed over time, and how often nurses needed to refill the humidifier device as a measure of added workload. The reported data shows that, for the primary measure of tube blockage, the heated humidifier group had an average change in tube volume of 8.81%, while the mist humidifier group had an average change of 14.08%. In plain terms, researchers measured how much the inside of the breathing tube had narrowed by filling it with a small amount of fluid and recording how much it could hold — a higher percentage change suggests more build-up inside the tube. For the nursing workload measure, the reported data shows the heated humidifier group required refilling an average of 0.0 times, while the mist humidifier group required refilling an average of 3.5 times during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01613768 · results posted 10 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 29 participants, all of whom received the study drug eribulin mesylate. All 29 participants completed the study. The trial was measuring how tumours responded to the treatment, using a standard set of imaging-based rules called RECIST — which looks at changes in tumour size on CT or MRI scans — as well as how long any response lasted, how long it took for disease to worsen, and how many participants experienced significant side effects. The reported data shows that, of the 29 participants, 1 had a complete response (meaning all target tumour areas disappeared on scans), 2 had a partial response (meaning tumours shrank by at least 30%), and 23 had stable disease (meaning tumours neither shrank enough to count as a response nor grew enough to count as progression). The remaining 3 participants were not accounted for in those three categories — no further breakdown was reported for them. In total, 26 out of 29 participants fell into the "disease control" category, which combines complete responses, partial responses, and stable disease. For those whose tumours did respond (complete or partial), the reported middle value (median) for how long that response lasted was 33.7 weeks. The reported median time until the disease progressed across all participants was 18.0 weeks. The reported data also shows that 14 out of 29 participants experienced a severe or higher-grade side effect (graded 3 or above on a standard scale), though the specific nature of those side effects was not detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02926573 · results posted 11 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people — 55 in a gabapentin group and 55 in a placebo (dummy treatment) group. The trial was looking at pain management after surgery, specifically measuring how much narcotic (opioid) pain medication patients used while in hospital, as well as their self-reported pain levels and satisfaction with pain control. Of those who started, 44 people in the gabapentin group and 46 in the placebo group completed the trial. The reported data shows that for the primary outcome — the amount of narcotic pain medication used per day while in hospital — the gabapentin group recorded 1.60 mg/hour and the placebo group recorded 1.59 mg/hour, which are nearly identical figures. For pain scores measured using a 100-millimetre scale (where 0 means no pain and 100 means the worst possible pain), the reported data shows that pain at rest ranged from around 23–44 mm in the gabapentin group and 30–46 mm in the placebo group across different time points. Pain during coughing ranged from about 28–36 mm in the gabapentin group and 39–46 mm in the placebo group across time points. For patient satisfaction surveys at discharge, the numbers of participants rating their pain control across the available response categories were broadly similar between the two groups, though the specific category labels for those response options were not included 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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NCT00509002 · results posted 24 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 37 adults with advanced or recurring salivary gland cancer who were not suitable for curative surgery or radiotherapy. All 37 participants completed the study. The trial was testing a drug called gefitinib (also referred to as ZD1839) and was primarily measuring how many participants' tumours responded to the treatment — that is, whether tumours shrank, stayed the same, or grew during the study period. The reported data shows that, out of the 37 participants, no one experienced a complete response (where all measurable tumour signs disappeared) and no one experienced a partial response (where tumours shrank by more than 30%). The reported data shows that 18 participants had stable disease, meaning their tumours neither shrank enough to count as a response nor grew enough to count as progression. Thirteen participants experienced progressive disease, meaning their tumours grew or new lesions appeared. Six participants were recorded in a separate category, though the specific label for that group was not described in detail in the submitted data. No secondary outcome measures were included in the structured results data provided, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01576939 · results posted 14 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom completed the study with no dropouts. All participants received a type of radiation treatment called Intensity Modulated Radiotherapy (a technique that shapes the radiation beam to target a specific area). The trial was looking at mouth sores (known as oral mucositis) that can develop during radiation treatment for head and neck cancer — specifically, how long it took for mouth sores to appear and how long they lasted. It also looked at pain levels, soreness, and the amount of pain-relief medication participants reported using. The reported data shows that, for the primary measurements, mouth sores were first observed at around 34 days and 29 days from the start of treatment (two separate measurements were taken for each participant, which is why two figures appear). Once mouth sores of a moderate-to-severe level (graded 2 or higher on a standard medical scale) were observed, they lasted approximately 25.7 days and 27.9 days respectively. For the secondary measurements, the reported data shows participants self-reported using roughly 917.5 mg and 1,214.3 mg of narcotic pain relief medication over the course of treatment — though the trial notes that self-reported medication use can be unreliable. On a soreness scale of 0 to 10, participants reported scores of approximately 2.9 and 3.7, while on a separate mouth pain scale of 0 to 10, scores of approximately 2.3 and 3.3 were reported. It is worth noting that because each participant contributed two measurements to the data, pairs of figures appear throughout the results. The trial did not include a comparison group, so the reported numbers reflect only the single group of 30 participants who received the treatment studied. 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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NCT01267240 · results posted 14 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom completed the study. Every participant received the same combination of two medicines: capecitabine and vorinostat. The trial was measuring how many people's tumours responded to the treatment combination, and how long participants lived or went without their cancer getting worse. The reported data shows that out of the 25 participants, 2 had a measurable reduction in their tumour size that met the trial's definition of a response (meaning the tumour either disappeared completely or shrank by at least 30%). For survival, the reported data shows a median overall survival — that is, the midpoint figure at which half of participants had passed away and half had not — of 10.8 months from the start of treatment. The reported data also shows a median progression-free survival — the midpoint figure for how long it was before participants' cancer grew, they passed away, or they completed the one-year follow-up — of 2.3 months. It is worth noting that this was a single-group trial with no comparison group, and all figures above reflect only the 25 people who took part. 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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NCT00703976 · results posted 4 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT00703976) involved 78 people in total. Participants were split into two groups: 37 people received a combination of cetuximab, pemetrexed, and radiation therapy, while 41 people received the same combination with the addition of a fourth treatment called bevacizumab. The trial was measuring how many participants went two years without their disease getting worse (called "progression-free survival"), and how many were still alive after two years ("overall survival"). The reported data shows that when looking at disease progression at the two-year mark, 79% of participants in the three-treatment group had not seen their disease worsen, compared with 75% in the four-treatment group. For overall survival at two years, the reported data shows that across all 78 participants combined, 88% were still alive. When broken down by group, 91% of the three-treatment group and 87% of the four-treatment group were reported as still living at the two-year point. It is worth noting that these figures are estimates based on the study's statistical methods, and the trial was not designed to directly compare the two groups against each other in a definitive way — the numbers simply describe what was observed and recorded for each group during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01065844 · results posted 19 December 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people, all of whom received a treatment called Nelfinavir. The trial was measuring how tumours responded to the treatment — specifically, whether tumours shrank, stayed the same size, or grew. Ten participants completed the trial, while five did not finish. The reported data shows that tumour response was measured using a standard system called RECIST (a set of rules researchers use to categorise changes in tumour size). There were four possible categories: complete response (tumour disappears entirely), partial response (tumour shrinks significantly), stable disease (tumour neither shrinks nor grows meaningfully), and progressive disease (tumour grows). According to the results submitted, zero participants fell into the complete response category, zero into the partial response category, seven were recorded as having stable disease, and four were recorded as having progressive disease. No other outcome measures were reported in the submitted data. It is worth noting this was a small trial with only 15 participants, and the results reflect only what was observed in this specific group of people under the conditions of this study. The reported data describes what was measured and recorded — it does not on its own tell us what the treatment will do for any individual person. 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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NCT01310179 · results posted 10 June 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, and all 12 completed the study — none dropped out. The trial was testing a combination treatment called Ad/PNP together with a drug called Fludarabine Monophosphate (sometimes referred to as F-araAMP) in people with tumours. The study was looking at two main things: what unwanted effects (side effects) participants experienced, and whether the size of their tumours changed during the treatment. The reported data shows that the primary focus — tracking side effects — found that all 12 participants experienced at least some unwanted effects. The data also shows that 8 out of 12 participants had certain other commonly observed unwanted effects (reported twice in the data, suggesting two separate side effect categories each affecting 8 people), and 5 out of 12 participants had another category of unwanted effect. The exact names of these specific side effect categories were not included in the structured data provided, so further detail cannot be described here. For the secondary outcome — changes in tumour size, measured physically with a ruler — the reported data shows that out of the 12 participants, 2 were recorded in one response category, 5 in another, and 5 in a third category. The labels describing what each of those categories meant (for example, whether a tumour grew, shrank, or stayed the same) were not included in the structured data submitted, so the specific meaning of these groupings cannot be described further. 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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NCT01219673 · results posted 10 February 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01219673) was testing whether three drugs — armodafinil, minocycline, and bupropion — used alone or in various combinations, could reduce a cluster of five symptoms (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite) in people receiving chemotherapy and radiation treatment for head and neck cancer. Symptoms were measured using a standard questionnaire called the MDASI-HNC, where each symptom is rated from 0 (not present) to 10 (as bad as you can imagine), with lower scores indicating fewer or milder symptoms. The reported data shows that only one participant was enrolled across all eight treatment groups combined — specifically in the minocycline-alone group — and that single participant completed the study. All other groups, including placebo, reported zero participants starting or finishing the trial. Because only one participant was enrolled in total, the reported data shows no results for the primary outcome measure — the average symptom score across the five symptoms. No numerical findings were reported for any of the treatment groups, meaning it is not possible to draw any conclusions from this trial's data as submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00500760 · results posted 5 August 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00500760) enrolled 89 people in the group receiving panitumumab (a targeted medicine) combined with chemoradiation (chemotherapy plus radiotherapy), and 64 people in the group receiving chemoradiation alone, for a total of 153 participants. The trial was studying people with head and neck cancer, and the main thing it was measuring was whether the cancer in the head and neck area was still under control two years after treatment — called the "local regional control rate." It also tracked a number of secondary measures, including disease control at 6 and 12 months, how long that control lasted, how long people lived without their disease getting worse (progression-free survival), overall survival, and how many people showed a measurable reduction in their cancer by 6 months. The reported data shows that at the two-year mark, the proportion of participants whose cancer remained under control in the head and neck area was 0.61 (roughly 61 in every 100 people) in the panitumumab-plus-chemoradiation group, and 0.68 (roughly 68 in every 100 people) in the chemoradiation-alone group. For the secondary measures, local regional control rates at 6 months were reported as 0.70 and 0.73 respectively, and at 12 months as 0.66 and 0.70. The median duration of local regional control was reported as 33.7 months for the panitumumab group; a median figure for the chemoradiation-alone group was not reported in the data. Similarly, median overall survival was 33.7 months for the panitumumab group, while the figure for the chemoradiation-alone group was not reported. Progression-free survival median figures were not reported for either group. At six months, the percentage of participants showing a measurable reduction in cancer (complete or partial response) was reported as approximately 71% in the panitumumab group and approximately 82% in the chemoradiation-alone 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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NCT00971932 · results posted 10 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 33 people, all of whom received a combination of three treatments: cetuximab, a platinum-based chemotherapy (either cisplatin or carboplatin), and a drug called 5-fluorouracil (5-FU). Of the 33 who started, 26 completed the study and 7 did not. The trial was primarily looking at how many participants showed a measurable shrinkage in their cancer — either a complete disappearance or a significant reduction in tumour size — as judged by an independent review panel using a standard set of measuring rules. The reported data shows that, using the primary measuring system (modified WHO criteria), 36.4% of participants met the criteria for a meaningful tumour reduction (complete or partial response). Using a second, separate set of measuring rules (called RECIST criteria), the reported figure was 45.5%. When the researchers also counted participants whose cancer neither shrank significantly nor grew significantly (called "stable disease"), 87.9% of participants fell into that broader combined category. The reported data also shows that, for those who did show a response, that response lasted a median (the middle value in a ranked list) of 2.8 months. The median time before the cancer started growing again was reported as 4.1 months, and the median overall survival time — from the start of treatment — was reported as 12.8 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00400205 · results posted 4 January 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, all of whom received a combination of three medicines: docetaxel, cisplatin, and 5-fluorouracil. Nine participants completed the trial, while five did not finish. The trial was measuring two main things: firstly, how many participants showed a reduction in their tumour size according to a standardised scoring system called RECIST (which looks at whether tumours disappeared completely or shrank by more than 30%); and secondly, whether a protein marker in the tumour tissue — called acetylated tubulin — measured before treatment could be linked to how much the tumour's stage (a measure of how advanced the cancer is) changed after three rounds of treatment. The reported data shows that, out of the 14 participants, 8 met the criteria for a tumour response under the RECIST system — meaning their tumours either disappeared completely or shrank by more than 30%. For the secondary outcome, the reported data shows two separate figures for tumour stage change: one group recorded an average change of -0.8% and another recorded -0.36%, where a negative number indicates the tumour stage decreased (i.e. moved in a reducing direction) after treatment. The trial was also examining whether the acetylated tubulin score measured before treatment could predict these changes, though further detail on that breakdown was not reported in the structured data here. It is worth noting that this was a very small trial with only 14 participants, so the numbers above reflect a narrow group of people. 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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NCT00700440 · results posted 26 March 2010
According to the results reported on ClinicalTrials.gov, this trial (NCT00700440) enrolled 100 participants, all of whom received cetuximab combined with chemoradiotherapy (a treatment combining chemotherapy and radiation therapy at the same time). The trial was looking at how well this combination controlled the disease in the local area of the body where the cancer was located (called "loco-regional control"), measured at three months after treatment. All 100 participants completed the study. The reported data shows that, at the three-month mark, all 100 out of 100 participants met the criteria for loco-regional control. This was assessed using a standardised measurement system called RECIST, which looks at whether tumours have disappeared completely or shrunk by at least 30% compared to their size at the start of the trial. The trial also intended to measure outcomes at one, three, and five years — including how long participants lived without the disease spreading — however, the reported data shows that no numerical results for those longer-term measures were submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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.