Reported trial results for Endometrial Cancer
Every Endometrial 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.
64 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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NCT04550429 · results posted 30 April 2026
According to the results reported on ClinicalTrials.gov, this trial looked at whether changing the operating pressure of a device called the MyoSure Hysteroscopic Morcellator — a tool used during a type of uterine procedure — affected things like the surgeon's ability to see clearly, how long the procedure took, and how much fluid was used. A total of 19 people took part: 11 were treated using the device set to a lower pressure (60 mmHg) and 8 were treated at a higher pressure (80 mmHg). The trial used a method called block randomisation, which means participants were assigned to each group by a structured random process rather than by choice. The reported data shows that, despite 19 participants starting the trial, the results listing on ClinicalTrials.gov records zero participants as having "completed" the study, with all 19 listed under "not completed." No numerical results were reported for any of the six primary outcome measures — these included surgeon visualisation (assessed by a post-procedure survey), procedure duration, the weight of tissue removed, the volume of fluid used during the procedure, whether a water-removing medication called Lasix was given afterwards, and whether the pressure setting needed to be changed mid-procedure. The data for all of these outcomes was not reported. Because no outcome numbers were submitted to ClinicalTrials.gov, it is not possible to describe what the measurements found. 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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NCT02405221 · results posted 22 January 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants in total — 8 received the TA-CIN vaccine injected into the thigh, and 7 received it injected into the arm. All participants had a history of HPV16-related cervical cancer (ranging from early to more advanced stages). The trial was primarily looking at whether the vaccine could be given safely via these two injection sites, and also measured certain immune system responses in the blood before and after vaccination. Twelve of the 15 participants completed the trial (6 in each group), with 3 not completing it (2 in the thigh group and 1 in the arm group). The reported data shows that, for the primary measure of treatment-related adverse events (unwanted side effects possibly linked to the vaccine), 5 out of 8 participants in the thigh group and 3 out of 7 participants in the arm group experienced such events. For one secondary measure — antibody levels in the blood (antibodies being proteins the immune system produces in response to something foreign) — the reported figures for the thigh group were 1.03, 0.91, and 0.32 absorbance units across three different antibody targets (HPV16 E6, E7, and L2), while the arm group recorded 1.27, 0.66, and 0.17 absorbance units for the same targets. These numbers reflect levels detected using a laboratory measurement technique. For the remaining secondary outcomes — including T-cell responses and immune cell activity in the blood — the data was not reported 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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NCT04269200 · results posted 23 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04269200) enrolled people with newly diagnosed advanced or returning endometrial cancer (cancer of the lining of the uterus). A total of 718 participants took part in the main "Global Cohort" — 241 received standard chemotherapy alone (paclitaxel and carboplatin), 238 received chemotherapy plus a drug called durvalumab, and 239 received chemotherapy plus durvalumab and a second drug called olaparib. A separate smaller group of 129 people in China was also tracked. The trial was primarily measuring how long participants went without their cancer growing or spreading — known as "progression-free survival" — and also tracked a number of other outcomes such as overall survival, how many people's tumours shrank, and how long those responses lasted. The reported data shows that in the Global Cohort, the median progression-free survival (meaning the point at which half the participants in each group had experienced disease progression or death) was 9.6 months for the standard chemotherapy group, 10.2 months for the chemotherapy plus durvalumab group, and 15.1 months for the chemotherapy plus durvalumab plus olaparib group. For the China Cohort, the reported figures were 9.7, 9.9, and 9.9 months respectively. On the secondary measures, the proportion of participants whose tumours shrank (objective response rate) was reported as 55.1%, 61.9%, and 63.6% across the three Global Cohort groups. The reported data shows that how long those responses lasted (duration of response) in the Global Cohort was 7.7 months, 13.1 months, and 21.3 months for the three groups. Overall survival and time to first subsequent therapy data were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01676818 · results posted 6 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people, all of whom received a treatment called eribulin mesylate. Thirty participants completed the study, while two did not. The trial was measuring two main things: how long participants went without their cancer getting worse (called progression-free survival), and how many participants experienced serious unwanted medical events (called serious adverse events) during treatment. The reported data shows that the median progression-free survival — meaning the middle point at which half of participants had experienced disease progression or death and half had not — was 2.5 months. In terms of serious adverse events, 25 out of 32 participants were reported to have experienced at least one serious adverse event. For the secondary outcomes, the reported data shows that when looking at participants' best overall response to treatment: 1 participant had a complete response (all measurable signs of cancer disappeared), 5 had a partial response (tumours shrank by at least 30%), 13 had stable disease (tumours neither shrank enough to count as a response nor grew enough to count as progression), and 11 had progressive disease (tumours continued to grow). The median overall survival — the middle point at which half of participants had died — was reported as 6.5 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.
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NCT04363957 · results posted 14 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04363957) enrolled 80 people in total — 40 in each of two groups. One group went through a standard consent process before a type of internal radiation treatment called brachytherapy, while the other group went through the same standard consent process but also watched a video about the treatment. The trial was measuring how satisfied patients felt with the consent process and how anxious they felt about their treatment. The reported data shows that satisfaction was measured using a questionnaire with 12 questions, where scores could range from 12 (lowest satisfaction) to 60 (highest satisfaction). At the starting point (before the consent process), both groups reported very similar satisfaction scores — 54 out of 60 for the standard consent group and 55 out of 60 for the video group. Anxiety was measured on a scale from 0 to 10, where a higher number means more distress. At that same starting point, both groups reported an average anxiety score of 4 out of 10. Results for the other time points measured during the study — after the consent process and before the final treatment session — were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03898167 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, this trial involved 2,474 people across three groups, all of whom were overdue for cervical cancer screening. The trial was measuring whether different ways of reaching out to these individuals would lead to more of them getting screened within six months. The three approaches tested were: a telephone reminder call, a mailed HPV self-sampling kit (where people collect their own sample at home), and a mailed HPV self-sampling kit combined with extra support from a patient navigator (someone who helps guide a person through the healthcare process). The reported data shows that, of those who started the study, 144 out of 828 people in the telephone reminder group completed cervical cancer screening within six months. In the mailed self-sampling kit group, 340 out of 828 people completed screening. In the group that received both the mailed kit and patient navigation support, 381 out of 818 people completed screening. For those who returned a self-collected sample and received an HPV test result, the reported data shows that in the mailed kit group, 38 tested positive, 288 tested negative, and 14 returned samples that could not be properly analysed. In the mailed kit plus navigation group, 49 tested positive, 312 tested negative, and 20 returned samples that could not be analysed. Regarding follow-up after an abnormal result, among those in the mailed kit group, 22 attended follow-up and 14 did not; in the navigation group, 33 attended follow-up and 15 did not. Follow-up figures for the telephone group were very small, as only 6 people in that group returned a self-collected sample. 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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NCT03104699 · results posted 30 July 2025
According to the results reported on ClinicalTrials.gov, this trial tested a drug called balstilimab across two phases. In Phase 1 (the dose-finding stage), 50 participants were split across five different dose levels, with 10 people in each group. In Phase 2 (the larger expansion stage), 161 participants all received what had been identified as the recommended dose. The trial was measuring things like how often serious side effects occurred at different doses, how the drug moved through the body at different dose levels, and — in Phase 2 — how many participants' tumours shrank or disappeared as assessed by an independent review committee. The reported data shows that in Phase 1, none of the 50 participants across any of the five dose groups experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious treatment-related side effect within the first three weeks of treatment. All 50 participants in Phase 1 did experience at least one "treatment-emergent adverse event" (any medical occurrence that happened during treatment, not necessarily caused by the drug). For the drug concentration measurements, the peak level of balstilimab in the blood rose with each higher dose group, ranging from around 18–20 micrograms per millilitre at the lowest dose up to around 282–315 at the highest. For Phase 2, the reported "objective response rate" — meaning the percentage of participants whose tumours were recorded as having significantly shrunk or fully disappeared — was 15.6%. The reported data also shows receptor occupancy figures (a measure of how much of the drug's target on immune cells was being engaged) ranging roughly from 62% to 77% across the dose groups in Phase 1, though the data as submitted appears to include multiple timepoints in a way that makes direct group-by-group comparison unclear. 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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NCT04693234 · results posted 27 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04693234) enrolled 178 people in total across two groups: 138 people received a combination of two medicines called ociperlimab and tislelizumab (Cohort 1), and 40 people received tislelizumab on its own (Cohort 2). The trial was measuring what is called the "objective response rate" — that is, the proportion of participants whose tumours showed a confirmed shrinkage (either a complete disappearance or a partial reduction in size) according to standardised imaging criteria. The trial also looked at how long any such response lasted. The reported data shows that in Cohort 1 (the combination group), 22.5% of all treated participants showed a confirmed tumour response as assessed by an independent review committee. When looking only at participants whose tumours had a particular protein marker present (called PD-L1 positive, meaning a score of 5% or above), that figure was 26.2%. In Cohort 2 (tislelizumab alone), the reported response rate among all treated participants was 32.5%. When the treating doctors themselves assessed responses — rather than the independent committee — the figures were 21.0% for Cohort 1 and 22.5% for Cohort 2 across all participants, and 25.0% and 30.0% respectively among the PD-L1-positive subgroup. Notably, the data for how long responses lasted (duration of response) was not reported in the submitted results. It is also worth noting that the results show zero participants listed as having formally "completed" the study, with all participants recorded as "not completed" — the reasons for this were not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02684227 · results posted 19 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02684227) looked at a combination of three medicines — enzalutamide, carboplatin, and paclitaxel — in women with advanced or returning endometrial (uterine) cancer. The trial was split into two parts: a smaller safety lead-in group (Part A, 7 participants) and a larger main phase (Part B, 43 participants), giving a total of 50 participants across both parts. The trial was measuring how many tumours shrank or disappeared, how long participants went without their cancer getting worse, and how long participants survived overall. The reported data shows that in Part A, 68% of participants had their tumour shrink or disappear (what researchers call an "objective response"), while in Part B this figure was 62%. For how long participants went without their disease getting worse (called "progression-free survival"), the reported median — meaning the midpoint figure where half did better and half did worse — was around 14.2 months in Part A and 13.3 months in Part B. For overall survival, a median figure was only reported for Part B, at approximately 36.1 months; the data was not reported for Part A. Regarding treatment-related unwanted effects (adverse events), the reported data shows some events occurred across both groups, though the figures as submitted are not clearly broken down in a way that allows plain description beyond noting they were recorded. 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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NCT04300647 · results posted 7 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04300647) enrolled 172 participants in total. Before a planned crossover point, 45 people received a drug called atezolizumab on its own, and 127 people received atezolizumab combined with a second drug called tiragolumab. After the crossover, 17 participants moved to the combination treatment. The trial was primarily measuring the "objective response rate" — that is, the percentage of participants whose tumours shrank or disappeared by a defined amount, as assessed by an independent review committee. The reported data shows that, for the main outcome, 15.6% of participants in the atezolizumab-alone group and 19.0% in the combination group met the criteria for a tumour response. For a broader measure called "disease control rate" — which also counted participants whose disease stayed stable — the figures reported were 20.0% for the monotherapy group and 31.0% for the combination group. Among those who did show a response, the reported median duration of that response (how long it lasted on average, in months) was not reported for the monotherapy group, while it was 11.8 months for the combination group. Investigators also assessed a "best clinical response rate," which was reported as 33.3% for the monotherapy group and 44.4% for the combination group, lasting a median of 7.0 and 5.5 months respectively. Regarding unwanted medical events (called adverse events) that were recorded during the trial, 41 of 45 participants in the monotherapy group, 118 of 127 in the pre-crossover combination group, and 14 of 17 in the post-crossover group had at least one such event recorded; the data does not break down the nature or severity of these events 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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NCT04508309 · results posted 30 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,025 participants across five groups, each receiving two doses of an HPV (human papillomavirus) vaccine on different schedules. Four groups received two doses of Cecolin (a two-strain HPV vaccine) spaced either 6, 12, or 24 months apart, or a first dose of Gardasil (a four-strain HPV vaccine) followed by a Cecolin dose 24 months later. A fifth group received two doses of Gardasil 6 months apart. The trial was measuring the immune response — specifically, the level of antibodies (proteins the body produces in response to vaccination) against two HPV strains (HPV-16 and HPV-18) that each participant's blood showed one month after their second dose. The reported data shows that, for HPV-16 antibody levels (measured in international units per millilitre, or IU/mL), the figures one month after the second dose ranged from 1,352.4 IU/mL in the Gardasil 0-and-6-month group up to 3,326.1 IU/mL in the Cecolin 0-and-24-month group. For HPV-18 antibodies, the reported figures ranged from 306.1 IU/mL (Gardasil 0-and-6-month group) to 535.2 IU/mL (Cecolin 0-and-24-month group). A separate measure — neutralising antibody levels (another way of quantifying immune response) — was also reported for a subset of participants, and these numbers followed a broadly similar pattern across groups. Notably, the reported seroconversion rate (the proportion of participants whose antibody levels rose at least fourfold from their starting level) was 100% across all five groups for both HPV-16 and HPV-18. The reported data also shows that neutralising antibody levels measured 18 months after the second dose were available only for the two groups that received their second dose at the 6-month mark (one Cecolin group and one Gardasil group), with figures of 1,541.9 and 1,368.1 respectively for HPV-16, and 441.7 and 423.4 respectively for HPV-18 — these figures were not reported for the other groups at that later time point. Nearly all participants who started the trial completed it, with only four participants across all groups not finishing. 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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NCT02630823 · results posted 3 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02630823) involved 10 participants, all of whom received the study treatment, MK-3475 (also known as pembrolizumab). Eight of the 10 participants completed the study, while 2 did not complete it. The trial was primarily measuring the number of participants who experienced side effects that were considered related to the treatment. It also tracked a measure called progression-free survival — that is, the length of time from when treatment started until either the disease got worse or a participant passed away. The reported data shows that for the main safety measures, all 10 participants experienced at least some level of treatment-related side effect at some point during the trial. When looking specifically at more serious side effects (graded "3 or higher" on a standard medical severity scale, meaning significant or severe), the reported data shows that 4 participants experienced at least one of these at some point. It is worth noting that the data includes multiple measurements recorded across different points in time, so these numbers reflect how many people were affected at various stages rather than a single snapshot. For the secondary outcome, the reported data shows that the median progression-free survival — meaning the midpoint figure for how long participants went before their disease worsened or they passed away — was approximately 201.3 weeks (roughly just under four years). The trial involved a very small number of participants (10 people), and no comparison group was included, so the numbers reflect observations within this one 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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NCT03884101 · results posted 16 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03884101) enrolled 842 people — 420 in a group receiving lenvatinib plus pembrolizumab, and 422 in a group receiving paclitaxel plus carboplatin (a standard chemotherapy combination). The trial was measuring how long participants went without their cancer growing or spreading (called progression-free survival), how long participants overall survived, and what proportion of participants saw their tumours shrink or disappear. The trial looked at results both across all participants and within a specific subgroup whose tumours had a particular biological feature called "mismatch repair proficient" (pMMR — meaning the tumour's DNA repair system was working normally). The reported data shows that, looking at all participants, the lenvatinib plus pembrolizumab group had a median progression-free survival (the point at which half the group had experienced disease progression or death) of 12.5 months, compared with 10.2 months in the chemotherapy group. In the pMMR subgroup only, those figures were 9.6 months versus 10.2 months respectively. For overall survival across all participants, the reported median was 37.7 months in the lenvatinib plus pembrolizumab group and 32.1 months in the chemotherapy group; in the pMMR subgroup, the figures were 30.9 months and 29.4 months. Regarding tumour shrinkage, the reported data shows that among all participants, 56.0% in each group had their tumours shrink or disappear; in the pMMR subgroup, that figure was 50.9% for lenvatinib plus pembrolizumab and 55.2% for chemotherapy. It is worth noting that the data shows zero participants were recorded as having "completed" the trial in either group, and the reasons for non-completion were not broken down further 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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NCT04551950 · results posted 8 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04551950) enrolled 25 people in total across three groups. Eight participants were in Cohort 1A, who received bintrafusp alfa combined with cisplatin or carboplatin, paclitaxel, and bevacizumab. Nine participants were in Cohort 1B, who received bintrafusp alfa with cisplatin or carboplatin and paclitaxel. Eight participants were in Cohort 2, who received bintrafusp alfa with cisplatin and radiotherapy. The trial was primarily measuring two things: how many participants experienced "dose-limiting toxicities" (that is, serious side effects severe enough to limit the dose of the study drug) and how many experienced adverse events (unwanted medical occurrences) or serious adverse events during treatment. The reported data shows that, for dose-limiting toxicities, zero participants in Cohort 1A experienced them, two out of nine participants in Cohort 1B experienced them, and zero participants in Cohort 2 experienced them. For treatment-emergent adverse events (unwanted medical occurrences that appeared or worsened during the treatment period), all participants in every group reported at least one — that is, all 8 in Cohort 1A, all 9 in Cohort 1B, and all 8 in Cohort 2. Among those, the number who experienced a *serious* adverse event (one resulting in outcomes such as hospitalisation or being life-threatening) was reported as 7 out of 8 in Cohort 1A, 4 out of 9 in Cohort 1B, and 6 out of 8 in Cohort 2. Several secondary outcomes relating to how the drug moves through the body over time (such as blood concentration levels at various points) were listed in the trial record, but the reported data shows no numerical results were submitted for any of those measures — so those figures are not available to describe 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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NCT04246489 · results posted 9 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 146 adults who received a drug called bintrafusp alfa. All 146 participants were recorded as having completed the study. The trial was measuring how their tumours responded to the treatment, using a standard set of imaging-based rules called RECIST v1.1, which classifies responses by looking at whether tumours shrank, stayed the same, or grew. The reported data shows that the main (primary) thing being measured was how many participants had a confirmed tumour response — meaning their tumours either disappeared entirely or shrank by at least 30% on two separate checks at least four weeks apart. According to the results reported on ClinicalTrials.gov, 32 out of 146 participants met this definition, as judged by an independent review committee. A separate assessment by the treating doctors recorded 25 out of 146 participants meeting the same definition. Of those who responded, 19 participants had a response that lasted at least six months, which the trial called a "durable response." The reported data also shows that the median time before disease progressed or participants passed away was 1.9 months (this "median" figure means half of participants reached that point before 1.9 months and half after). The duration of response figure was listed as "NA," meaning that particular result was not reported in the data submitted. Regarding unwanted medical events (called adverse events), 145 out of 146 participants experienced at least one event that occurred during treatment, and 106 experienced at least one event considered related to the study drug; other specific event figures were also reported but without labels distinguishing what each number refers to 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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NCT01367002 · results posted 18 April 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 29 in a group receiving a chemotherapy combination (carboplatin and paclitaxel) and 32 in a group receiving trastuzumab (a targeted medicine). The trial was looking at a type of uterine cancer called uterine serous papillary carcinoma (USPC). The main thing being measured was how long participants went without their cancer getting worse — known as "progression-free survival." The trial also recorded response to treatment, overall survival (how many people were still alive at the end of the study period), and adverse (unwanted) events. The reported data shows that, for the primary measure, the carboplatin/paclitaxel group went a reported average of about 8 months without their cancer progressing, while the trastuzumab group went about 13 months. For overall survival, the data shows 7 out of 28 participants in the carboplatin/paclitaxel group and 9 out of 30 in the trastuzumab group were reported as surviving through the study period. Regarding adverse events (unwanted health events during the trial), 6 participants in the carboplatin/paclitaxel group and 14 in the trastuzumab group experienced serious adverse events; all 28 carboplatin/paclitaxel participants and all 32 trastuzumab participants were reported as experiencing some form of adverse event. For the response rate outcome, the reported data includes counts across several response categories, but the breakdown labels for each category were not included in the submitted data, so the full detail of 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00492778 · results posted 29 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT00492778) involved 165 people in total — 82 in one group receiving brachytherapy (internal radiation) and radiation therapy alone, and 83 in a second group receiving the same radiation treatment plus a chemotherapy medicine called cisplatin. The trial was measuring how many participants experienced their disease getting worse or dying, how many died overall, and how many experienced significant side effects during and after treatment. The reported data shows that, for the main outcome — the number of people whose disease progressed or who died — 27 out of 82 participants were recorded in the radiation-only group, compared with 35 out of 83 in the radiation-plus-cisplatin group. For overall deaths recorded during the study, 18 people in the radiation-only group and 21 in the radiation-plus-cisplatin group were reported to have died. The trial also looked at smaller subgroups of participants based on where their tumour was located and its type; the reported numbers of progression or death in those four subgroups were 45, 4, 0, and 13 respectively, though the data does not clearly specify which subgroup each number corresponds to in plain terms. Regarding significant side effects — those graded as serious (grade 3 or higher, meaning moderately severe to severe) — 37 out of those treated in the radiation-only group and 49 out of those in the radiation-plus-cisplatin group were reported to have experienced them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03422198 · results posted 23 December 2022
According to the results reported on ClinicalTrials.gov, this trial involved 108 people who had been diagnosed with endometrial (uterine) cancer and were receiving a type of internal radiation treatment called vaginal cuff brachytherapy. Participants were split into two equal groups of 54: one group received a shorter course of this radiation treatment, and the other received the standard-length course. The trial was measuring quality of life, feelings about femininity, and the cost of treatment. All 108 participants who started the trial completed it. Please note that some planned measurements — including a financial wellbeing questionnaire and questions about diet and physical activity — were not reported in the submitted data. The reported data shows that, one month after treatment, both groups had a very similar small change in their overall quality of life scores (using a 0–100 scale where higher means better quality of life): both the shorter-course group and the standard-course group showed an average increase of 2.08 points from their starting scores. For a question asking whether participants felt less feminine as a result of their disease or treatment (again on a 0–100 scale, where higher means feeling less feminine), the shorter-course group showed a small average increase of 0.65 points, while the standard-course group showed an average decrease of 6.25 points. The reported data does not include further detail explaining this difference. Regarding costs, the reported data shows that the average amount charged for procedures was approximately USD $33,205 for the shorter-course group and approximately USD $45,920 for the standard-course group — a difference of roughly USD $12,700. These figures reflect charges in the United States and may not be directly relevant to the Australian healthcare setting. 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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NCT00923702 · results posted 20 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT00923702) enrolled a total of 22,729 participants across five groups: those who received three doses of the HPV vaccine (4,348 people), two doses (4,979 people), two doses by default (3,452 people), a single dose (4,950 people), and an unvaccinated comparison group (5,000 people). The trial was measuring antibody levels in the blood in response to the HPV vaccine types covered (HPV 16, 18, 6, and 11), as well as how often persistent HPV infection and HPV-related precancerous or cancerous cervical changes occurred across the groups. The reported data shows that antibody levels — measured using a laboratory intensity scale called "median fluorescence intensity" (essentially a way of quantifying how much antibody is present in a blood sample) — were 5,460 in the three-dose group, 6,125 in the two-dose group, 437 in the two-doses-by-default group, and 106 in the single-dose group. No antibody data was reported for the unvaccinated group. For persistent HPV 16/18/6/11 infections, the reported data shows 1 infection recorded in each of the three-dose, two-dose, and single-dose groups, 4 infections in the two-doses-by-default group, and 32 infections in the unvaccinated group. No data was reported for the outcome measuring HPV 16/18-associated precancerous lesions or cancers, nor for the two secondary outcomes relating to other HPV types not included in the vaccine. 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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NCT03103087 · results posted 20 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 382 women across three groups: 126 received relugolix combined with the hormones estradiol and norethindrone acetate (referred to here as "relugolix plus add-back hormones"), 127 received relugolix with the add-back hormones introduced after a short delay, and 129 received a placebo (inactive treatment). The trial ran for up to 24 weeks and was measuring several things related to uterine fibroids, including menstrual blood loss, period absence, pain, blood counts, and fibroid size. The pre-specified comparisons in the results focused on the relugolix plus add-back hormones group versus the placebo group. The reported data shows that for the primary measure — the proportion of women whose menstrual blood loss both fell below 80 mL and dropped by at least half from where it started — 71.2% in the relugolix plus add-back hormones group met this target, compared with 14.7% in the placebo group. For the secondary measures, the reported data shows: 50.4% of the relugolix plus add-back hormones group had no measurable period (amenorrhea) over the last 35 days of treatment, versus 3.1% in the placebo group; average menstrual blood loss fell by 84.3% from the starting point in the relugolix plus add-back hormones group, compared with 15.1% in the placebo group. Among participants who began the trial with low haemoglobin (a marker related to blood iron levels), 61.3% in the relugolix plus add-back hormones group saw their haemoglobin rise by more than 2 g/dL by week 24, versus 5.4% in the placebo group. The reported data also shows that among participants who had moderate-to-severe fibroid-related pain at the start, 47.1% in the relugolix plus add-back hormones group recorded only minimal pain scores (a score of 1 or less out of 10) over the last 35 days of treatment, compared with 17.1% in the placebo group. The size of the primary fibroid, as measured by ultrasound, was reported to have decreased on average by 17.4% in the relugolix plus add-back hormones group and by 7.4% in the placebo group by week 24. Results for the delayed add-back hormones group (Group B) were not included in these pre-specified comparisons 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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NCT03886220 · results posted 31 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03886220) looked at a medication called elagolix (150 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with heavy menstrual bleeding related to uterine fibroids (non-cancerous growths in the womb). A total of 82 participants started the treatment period — 28 in the placebo group and 54 in the elagolix group. Of those, 65 completed the treatment period (23 and 42 respectively), and a follow-up period after treatment was also completed by most of those who entered it. The reported data shows that the main thing being measured was the proportion of participants whose menstrual blood loss dropped below 80 mL in the final month of treatment AND who also had at least a 50% reduction in blood loss compared to their starting level — these participants were called "responders." According to the results reported on ClinicalTrials.gov, 23.3% of participants in the placebo group met both of these conditions, compared to 49.4% of participants in the elagolix 150 mg group. No other outcome measure data was included in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03196180 · results posted 23 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 women who had been diagnosed with high-grade cervical cell changes (abnormal cells on the cervix confirmed by biopsy). Eleven of the 13 participants completed the study, while two did not finish. The trial was testing whether it was practical and tolerable for women to apply two topical (applied directly to the skin/tissue) treatments — fluorouracil and imiquimod — inside the vagina on alternating weeks. Researchers also looked at whether the cervical cell changes showed any regression (improvement toward normal), whether a virus linked to these changes (high-risk HPV) was cleared, and how certain immune-system markers in the body changed over the course of treatment. The reported data shows that, for the main question of feasibility, 4 out of 13 participants experienced specified adverse reactions (side effects of a certain severity) that were considered related to the treatment, and 1 out of 13 was unable to apply at least half of the doses because of those reactions. For the secondary outcomes, the reported data shows that 40% of participants showed a response — meaning their cervical cell changes moved from high-grade to low-grade or no abnormality, and high-risk HPV was no longer detected at the end of the study. The reported data also shows varying rates of clearance for specific HPV types, ranging from 0% to 100% depending on the particular type. Changes in immune markers (proteins called cytokines and cell receptors called Toll-like receptors) were also measured before and after treatment, with the numbers showing small increases or decreases depending on the specific marker; however, what these changes mean clinically was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01706705 · results posted 23 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 57 participants, all of whom were in a single group receiving a specialised brachytherapy (internal radiation) treatment planning approach. Of those 57 people who started, 37 completed the study and 20 did not. The trial was measuring whether a novel applicator device — used to deliver internal radiation treatment — could produce better quality medical scan images when positioned in two different ways: a "shifted" position and a "standard" position. Image quality was assessed both by a radiation specialist reviewing the scans and by a technical measure called Hounsfield units, which is a way of quantifying how clearly different tissues show up on a CT scan. The reported data shows that for the primary outcome — the number of participants who had improved image quality in the shifted position — the two figures recorded were 0 and 15 participants respectively. The same figures (0 and 15) were also reported for the secondary outcome, which looked at the number of participants with high quality images of the bladder, rectum and sigmoid (part of the large bowel) using the applicator in either position. No numerical results were reported to ClinicalTrials.gov for the remaining pre-specified outcome measures listed in the trial, so those findings are not available here. It is worth noting that the way these numbers are presented in the submitted data is limited — for example, it is not entirely clear from the reported figures alone which number corresponds to which position or comparison — and no further breakdown was provided in the structured 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.
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NCT03517449 · results posted 17 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03517449) enrolled 411 people in the lenvatinib plus pembrolizumab group and 416 people in the comparison group, who received a doctor-chosen chemotherapy (either doxorubicin or paclitaxel). The trial was measuring several things in people with a type of cancer called endometrial (uterine) cancer: how long participants went without their cancer growing or spreading (called progression-free survival), how long participants lived overall (called overall survival), and what proportion of participants saw their tumours shrink or disappear (called objective response rate). These measures were looked at in two groups of participants — those whose tumours had a particular biological feature called "mismatch repair proficient" (pMMR), and the full group of all participants combined (called "all-comers"). The reported data shows the following numbers. For how long participants went without their cancer growing, the lenvatinib plus pembrolizumab group reported a median of 6.6 months (pMMR participants) and 7.2 months (all-comers), compared with 3.8 months in both pMMR and all-comer groups for those receiving chemotherapy. For how long participants lived overall, the lenvatinib plus pembrolizumab group reported a median of 18.0 months (pMMR) and 18.7 months (all-comers), compared with 12.2 months (pMMR) and 11.9 months (all-comers) in the chemotherapy group. These figures are medians, meaning half the participants in each group reached that time point and half did not. For tumour shrinkage or disappearance, the reported data shows 30.3% of pMMR participants and 31.9% of all-comer participants in the lenvatinib plus pembrolizumab group met that measure, compared with 15.1% (pMMR) and 14.7% (all-comers) in the chemotherapy 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03438006 · results posted 8 September 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03438006) involved 3,013 participants who received the Cervarix vaccine (a cervical cancer vaccine). Of these, 2,895 completed the study and 118 did not. The trial was set up to track and count any unwanted health events — called adverse events following immunisation (AEFIs) — that occurred after each dose and across all doses combined. This included events serious enough to require an unplanned visit to a doctor or hospital. The reported data shows that, looking across all doses, 147 participants experienced a medically attended AEFI of any kind (meaning a health event that led to an unplanned medical visit). Of those, 2 were assessed by the study investigator as potentially related to the vaccination, and 1 was classed as severe enough to prevent normal daily activities. When broken down by individual doses, the figures reported were 49 participants after the first dose, 55 after the second, and 56 after the third. For more serious events — those requiring hospitalisation or meeting other serious criteria — 22 participants were reported to have experienced one; none of these were fatal and none were assessed as related to the vaccination. One participant was reported to have experienced a condition belonging to a special category of immune-related disorders (called potential immune-mediated diseases); this was not classed as severe and was not assessed as related to the vaccine. The reported data also shows that 34 participants became pregnant during the study period, with outcomes including 20 spontaneous miscarriages and 1 elective abortion for medical reasons; no congenital abnormalities were reported in that 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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NCT01536392 · results posted 17 May 2021
According to the results reported on ClinicalTrials.gov, this trial compared two anti-nausea medicines used during chemotherapy: a granisetron skin patch (worn on the body) and ondansetron tablets taken by mouth. A total of 41 people were enrolled in the skin patch group and 34 in the tablet group. Of those, 28 and 19 participants respectively completed the trial, meaning a notable number in both groups did not finish. The reported data shows that the trial measured how many participants had no vomiting or retching episodes and did not need any extra "rescue" anti-nausea medicine. This was looked at in two time windows after each chemotherapy session: the first 24 hours (called the "acute" phase) and days 4 to 7 (called the "late onset" phase). According to the results reported on ClinicalTrials.gov, the numbers were the same for both time windows: approximately 49.8% of participants in the skin patch group and 39.7% of participants in the tablet group met this no-vomiting, no-rescue-medicine measure. The trial also collected information on quality of life related to nausea and vomiting, and on how consistently participants took their medication, though detailed breakdowns of those scores were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03400956 · results posted 30 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03400956) enrolled 103 participants across three groups. One group (35 people) received the drug vilaprisan continuously throughout the study. The other two groups (34 people each) took part in a crossover design — one group received a placebo first and then switched to vilaprisan, while the other received vilaprisan first and then switched to a placebo. The trial was looking at how vilaprisan affected menstrual bleeding in participants, particularly whether it stopped periods altogether and whether it reduced very heavy bleeding. The reported data shows that for the main outcome — stopping periods completely during the last 28 days of treatment — 29 out of 32 participants in the continuous vilaprisan group and 25 out of 31 participants in the vilaprisan-first crossover group met this measure, compared with just 1 out of 33 participants in the placebo group during their placebo phase. For the heavy menstrual bleeding outcome (bleeding dropping well below a set threshold and falling by more than half compared to the start), the reported data shows 30 out of 32 in the continuous vilaprisan group and 26 out of 31 in the vilaprisan-first group met this measure, compared with 7 out of 33 in the placebo group. The reported data also shows that for participants who went on to a second treatment period, the median time for bleeding to come under the defined threshold was around 1 to 1.5 days. For endometrial tissue samples (a lining-of-the-womb check), no cases of malignancy or abnormal cell growth were reported across any of the groups, though the data was not reported for all participants who started the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02354534 · results posted 2 April 2021
According to the results reported on ClinicalTrials.gov, this trial looked at artesunate suppositories (a medicine inserted into the vagina) in people with a cervical cell change called CIN2/3, which is caused by the human papillomavirus (HPV). A total of 30 people took part across four groups, receiving either a lower dose (50 mg for one treatment cycle) or a higher dose (200 mg for one, two, or three treatment cycles). The trial was primarily measuring whether the treatment caused any serious unwanted medical events, and secondarily whether HPV became undetectable and whether the abnormal cervical cells reduced in severity — all without surgery. The reported data shows that across all four groups, no participants experienced a serious adverse event (a significant harmful medical reaction) that was linked to the study treatment. For the secondary measurements, the reported data shows that out of the 30 participants, 9 in total had their HPV strains become undetectable during the study (1 in the 50 mg group, 3 in the one-cycle 200 mg group, 4 in the two-cycle 200 mg group, and 1 in the three-cycle 200 mg group). Regarding the cervical cell changes, 19 participants in total showed a reduction from the higher-grade abnormality (CIN2/3) to a lower-grade finding or normal (2, 7, 5, and 5 across the four groups respectively). One participant did not complete the study, and the reason for this was not reported in the 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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NCT01365156 · results posted 3 February 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01365156) enrolled 28 people with locally advanced cervical cancer — 14 in a surgery group and 14 in a chemoradiation group. All 28 participants were recorded as having completed the study with no drop-outs noted. The trial was set up to compare two approaches: one where patients first had a surgical procedure to check lymph nodes near the aorta (a large blood vessel in the abdomen) before receiving targeted chemoradiation (a combination of chemotherapy and radiation), versus a standard approach where imaging scans were used to guide whole-pelvic chemoradiation without prior surgery. The main thing being measured was overall survival — how long participants lived after treatment. The reported data shows, however, that no numerical results for the primary outcome measure (overall survival rate) were submitted or recorded in the ClinicalTrials.gov results entry. In other words, the actual survival figures for either group were not reported in the structured data available, so it is not possible to describe what the numbers showed. No secondary outcome measure data appears to have been submitted either. 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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NCT02005510 · results posted 16 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02005510) looked at whether mailing an at-home HPV self-testing kit to people overdue for cervical cancer screening would lead to more of them getting screened, compared to people who received the usual care from their clinic. In the first round, 8,120 people were placed in the in-home HPV screening group and 8,111 in the usual care group. Smaller groups were re-randomised in two further rounds for those who still had not been screened. The reported data shows that when it came to completing cervical cancer screening, 2,618 people in the in-home HPV group did so, compared with 1,719 in the usual care group. For abnormal screening results (meaning a result that needed further follow-up), 225 people in the in-home HPV group had one, compared with 114 in the usual care group. Regarding the two primary outcomes — detecting pre-cancerous cervical changes (called cervical intraepithelial neoplasia grade 2 or worse, meaning changes to cervical cells considered significant enough to monitor or treat) — 12 people in the in-home HPV group and 8 in the usual care group were diagnosed with this. Similarly, 12 people in the in-home HPV group and 7 in the usual care group went on to receive treatment for this condition. The trial also surveyed a smaller number of participants about their experiences and attitudes; 116, 156, 119, and 964 people in the in-home HPV group completed various survey components, and 46 and 29 participated in in-depth interviews, though no data was reported for the usual care group for 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02691494 · results posted 30 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02691494) enrolled 378 participants across three groups: 94 received a placebo (a dummy treatment), 95 received elagolix alone, and 189 received elagolix combined with estradiol and norethindrone acetate (referred to here as elagolix + E2/NETA, a hormone add-back combination). The trial was measuring menstrual blood loss (the volume of blood lost during a period) in women with uterine fibroids — non-cancerous growths in the womb that can cause heavy periods. The main thing the researchers were looking for was how many participants met two conditions at once: their monthly blood loss dropped below 80 mL, and it fell by at least 50% compared to where it started. The reported data shows that, for the primary measure — the proportion of participants meeting both of those conditions — 10.5% of the placebo group qualified as "responders," compared with 76.9% in the elagolix-alone group and 76.5% in the elagolix + E2/NETA group. For the secondary measures, the reported change in blood loss volume from the starting point to the final month was a reduction of about 4.3 mL in the placebo group, 198.8 mL in the elagolix-alone group, and 168.8 mL in the elagolix + E2/NETA group. Similar patterns were reported at the 3-month and 6-month points. The reported data also shows that complete suppression of bleeding during the final month was recorded in 4.7% of the placebo group, 88.9% of the elagolix-alone group, and 61.0% of the elagolix + E2/NETA group. One additional secondary measure looked at participants who started the trial with low haemoglobin (a protein in red blood cells, measured at or below 10.5 g/dL) and tracked how many saw their haemoglobin rise by more than 2 g/dL by month 6. The reported data shows this occurred in 20.8% of the placebo group, 40.0% of the elagolix-alone group, and 50.0% of the elagolix + E2/NETA 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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NCT02725268 · results posted 9 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02725268) enrolled 241 participants in total, split across four treatment groups: 90 people received paclitaxel alone (a chemotherapy drug), 90 received paclitaxel combined with a lower dose of sapanisertib (an investigational drug), 41 received a higher dose of sapanisertib alone, and 20 received a lower dose of sapanisertib combined with another investigational drug called MLN1117. The trial's main goal was to measure "progression-free survival" — that is, how long participants went before their cancer showed signs of growing or spreading, or before they passed away. The reported data shows that for the main measure — the length of time before the cancer progressed or death occurred — the paclitaxel-alone group had a median of 3.7 months, the paclitaxel-plus-sapanisertib group had 5.6 months, the sapanisertib-alone group had 2.1 months, and the sapanisertib-plus-MLN1117 group had 2.0 months. For overall survival (time from the start of the trial until death), the reported figures were 12.7 months, 13.8 months, 12.5 months, and 11.1 months for each group respectively. The reported data also shows that the percentage of participants whose tumours shrank meaningfully (called the "overall response rate") was 18.4% for paclitaxel alone, 24.4% for paclitaxel plus sapanisertib, 4.9% for sapanisertib alone, and 0% for the sapanisertib-plus-MLN1117 group. Regarding side effects, the reported data shows that nearly all participants in every group experienced at least one medical event after starting treatment — 87 out of 90 in the paclitaxel-alone group, 86 out of 90 in the paclitaxel-plus-sapanisertib group, all 41 in the sapanisertib-alone group, and all 20 in the sapanisertib-plus-MLN1117 group. The trial did not report further detail on the nature of those events in the summary 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01627288 · results posted 10 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in total across three active dose groups. No participants were enrolled in a planned fourth group (Dose Level 0). The trial was testing different radiation boost doses — 60, 65, and 70 Gray (Gray is a unit used to measure radiation) — given alongside chemotherapy (cisplatin) for cervical cancer that had spread to the lymph nodes. The main goal was to find the highest radiation boost dose that could be given without causing unacceptable side effects, while secondary goals looked at how long participants went without the cancer returning locally, how long before it spread elsewhere, and how long participants survived overall. The reported data shows that the highest dose tested — 70 Gray — was identified as the maximum tolerated dose across all treatment arms combined. For dose-limiting side effects (serious harmful reactions during or shortly after treatment), the reported data shows that 1 out of 12 participants across all groups experienced such a reaction, with that 1 case occurring in the highest dose group (70 Gray) and none reported in the 60 Gray or 65 Gray groups. Regarding the secondary outcomes, the reported figures for time without local or regional recurrence were: not reported for the 60 Gray group, approximately 0.65 years for the 65 Gray group, and approximately 1.52 years for the 70 Gray group. The reported data shows disease-free survival (time without any cancer returning) across all groups combined was approximately 1.3 years, and overall survival across all groups combined was approximately 1.6 years. Individual group figures for these measures were also reported but varied, and some results — particularly for the 60 Gray group — were listed as not available. It is worth noting that this was a very small trial with only 12 participants, and its purpose was primarily to test dose levels rather than to draw broad conclusions. 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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NCT02067468 · results posted 19 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,661 women across three groups to compare three different approaches for following up an abnormal cervical screening result. The three approaches were: immediate colposcopy (a close-up examination of the cervix), a repeat smear test (cytology), and an HPV test (a test for the human papillomavirus). Each group had around 880–890 participants, and all of them were followed up over two years, either through clinic visits or medical records. The reported data shows that the primary outcome — the number of women found to have a significant cervical cell change (called CIN2 or higher, meaning cell changes considered potentially serious) detected by local pathologists — was 30 out of 882 in the colposcopy group, 43 out of 890 in the cytology (smear test) group, and 31 out of 889 in the HPV test group. A secondary check involved an independent panel of expert reviewers re-examining tissue samples; they recorded 51 cases in the colposcopy group, 61 in the cytology group, and 48 in the HPV test group. At a final visit two years after joining the study — designed to look for any disease that the strategies may not have detected during the follow-up period — the expert panel found 30 cases in the colposcopy group, 39 in the cytology group, and 23 in the HPV test group. The reported data also shows that the total number of clinical procedures (smear tests, colposcopies, and tissue samples combined) over the two years was 2,440 in the colposcopy group, 2,076 in the cytology group, and 1,850 in the HPV test group. The trial also measured participants' self-esteem and anxiety levels at enrolment, shortly after receiving their test result, and again at one year. The reported data shows that self-esteem scores (on a scale of 10–40, where higher means better) were similar across all three groups at the start (around 32.8–33.0) and appeared to rise slightly over the year in all groups. Anxiety scores (on a scale of 0–60, where higher means more anxiety) were also similar at the start (around 17.4–17.7) and appeared to decrease slightly over time in all 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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NCT02270255 · results posted 5 August 2019
According to the results reported on ClinicalTrials.gov, this trial involved 44 people in total, split evenly into two groups of 22. One group received standard care (the control group), while the other received a procedure called a Superior Hypogastric Nerve Block — a type of pain-relieving nerve block targeting a specific group of nerves in the pelvis. The trial was measuring how much pain relief medication (morphine, or its equivalent) each group needed after their procedure before being discharged from the recovery room, with the goal of keeping pain below a score of 4 out of 10 on a simple pain scale where 0 means no pain and 10 means the worst pain imaginable. The reported data shows that, on average, people in the control group used 11 mg of morphine-equivalent pain medication in the recovery room, while people in the nerve block group used 5.1 mg. The trial also tracked whether anyone in the nerve block group experienced serious complications from the procedure itself, using a recognised grading system for medical complications. The reported data shows that no participants in either group experienced any of the more serious categories of adverse events (grades C through F, which cover things like needing extra treatment, prolonged hospital stays, lasting harm, or death). One person in the control group did not complete the full home survey after discharge, while all 22 participants in the nerve block group completed the study. It is worth noting that this was a relatively small trial of 44 people, and the results as reported here describe only what was measured in this specific 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00131365 · results posted 12 June 2019
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called ExAblate MRgFUS (a type of focused ultrasound guided by MRI scanning) and enrolled 9 participants in total. The main thing the trial was set up to measure was the number and type of unwanted or unexpected health events (known as adverse events) that occurred during the study. Of the 9 people who started, 5 completed the trial, while 4 did not finish. The reported data shows that a total of 15 adverse events were recorded across the group. In a separate, post-hoc analysis (meaning this was looked at after the study was already underway, rather than planned from the start), the data shows that 6 out of the 9 participants experienced at least one adverse event. No other outcome numbers — such as measures of how well the treatment performed — were included in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02228681 · results posted 24 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02228681) enrolled 74 people in total — 37 in each of two groups. All 74 participants completed the study. One group received a combination of everolimus and letrozole, while the other received tamoxifen and medroxyprogesterone acetate. The trial was looking at how often tumours shrank or disappeared (called a "response"), how long participants lived without their cancer getting worse, and how long they survived overall. The reported data shows that in the everolimus and letrozole group, 9 out of 37 participants had their tumour shrink or disappear (a confirmed response). In the tamoxifen and medroxyprogesterone acetate group, 8 out of 37 participants had a confirmed response. For the secondary measure of how long participants went without their cancer getting worse (called "progression-free survival"), the reported midpoint figure was 6.4 months in the everolimus and letrozole group and 3.7 months in the tamoxifen and medroxyprogesterone acetate group. For overall survival — how long participants lived from the start of the study — the midpoint figure for the tamoxifen and medroxyprogesterone acetate group was reported as 16.6 months, while the equivalent figure for the everolimus and letrozole group was listed as "not available" (meaning it was not reported or could not yet be calculated at the time of reporting). The trial also tracked side effects using a standard medical grading scale; the reported data shows that most participants in both groups experienced side effects of moderate severity, though the full breakdown across severity levels was recorded for both groups. Results for two planned biomarker (biological marker) analyses were 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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NCT01131312 · results posted 20 November 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01131312) involved three groups of women who were each screened for abnormal cells on the cervix using a different method: a standard cell sample (cytology/Pap test), an HPV DNA test, or a direct visual examination called colposcopy. A total of 5,060 women started the trial across the three groups — 1,839 in the cytology group, 1,385 in the HPV group, and 1,836 in the colposcopy group. The trial was measuring how often a serious type of abnormal cervical cell change, called CIN III (cells that have a higher chance of developing into cancer if left untreated), was detected by each screening method over the course of the study. The reported data shows that the percentage of participants found to have CIN III was similar across all three screening groups: approximately 10.93% in the cytology group, 10.25% in the HPV testing group, and 10.84% in the colposcopy group. For the secondary outcome — which looked at the combined detection of CIN II and above (a broader category that includes both moderate and more serious abnormal cell changes) over two years — the reported figures were 16.69% in the cytology group, 18.12% in the HPV group, and 20.75% in the colposcopy group. It is worth noting that a portion of participants did not complete the trial in each group, so these figures reflect those who were assessed rather than everyone who started. 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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NCT00729586 · results posted 27 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 73 people in total — 51 in one group who received a drug called temsirolimus on its own, and 22 in a second group who received temsirolimus combined with two hormone-based medicines (megestrol acetate and tamoxifen). Almost all participants completed the study (50 and 21 respectively). The trial was measuring how tumours responded to these treatments, how long participants lived, and how long it took before the disease progressed. The reported data shows that, for the primary measure — the percentage of participants whose tumours shrank or disappeared according to a standard set of scanning rules — 22% of people in the temsirolimus-only group had a confirmed tumour response, compared with 14.3% in the combination group. For survival, the temsirolimus-only group had a reported median overall survival (meaning the point at which half the group had passed away) of 13.3 months, versus 9.6 months in the combination group. The reported median time before the disease was recorded as getting worse was 5.6 months in the temsirolimus-only group and 4.2 months in the combination group. The reported data also shows that, when it came to serious side effects (graded 3 or higher on a standard medical scale, meaning significant or severe), 29 out of 51 participants in the temsirolimus-only group and 15 out of 22 participants in the combination group experienced at least one such event during treatment. A separate part of the study looked at biological markers in tumour tissue from around 20–35 participants, though those findings were noted as being for future investigation. 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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NCT02227316 · results posted 8 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants in total, split across four groups: 4 people received intravenous (IV) ibuprofen alone, 4 received IV paracetamol (acetaminophen) alone, 16 received both IV ibuprofen and IV paracetamol together, and 16 received a placebo (an inactive drip with no medicine). All 40 participants completed the study. The trial was designed to measure pain levels over 24 hours using a self-reported pain scale of 0 to 10 (where 0 means no pain and 10 means the worst possible pain), as well as nausea levels, and the amounts of other pain and anti-nausea medicines used during that time. The reported data shows that, for the primary measure of average maximum pain score over 24 hours, the numbers were 6.48 for the IV ibuprofen group, 7.27 for the IV paracetamol group, 6.16 for the combination group, and 5.30 for the placebo group. For average overall pain across the 24 hours, the reported scores were 4.52, 4.22, 3.90, and 3.34 for those same groups respectively. Regarding nausea (also rated 0–10), the average nausea scores were 1.52, 3.20, 3.59, and 2.38, while the reported peak nausea scores were 5.62, 5.25, 6.41, and 3.71 across the four groups. The reported data also shows that the average amount of opioid pain medicine used over 24 hours (measured in morphine equivalents, a standard way of comparing different opioid medicines) was 75.75 for the IV ibuprofen group, 69.63 for IV paracetamol, 48.44 for the combination group, and 62.28 for the placebo group. The average dose of anti-nausea medicine given was 16.00 mg, 19.50 mg, 22.25 mg, and 19.50 mg for the four groups 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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NCT00003702 · results posted 15 May 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 240 people in total — 120 in each of two groups. One group received a medicine called methotrexate (given as a weekly injection into the muscle), and the other received a medicine called dactinomycin (given as an intravenous push — meaning directly into a vein — every two weeks). The trial was looking at two main things: whether participants' levels of a hormone called hCG (human chorionic gonadotropin, a marker measured in the blood) returned to normal and stayed normal, and how many participants experienced significant side effects during treatment. A smaller number did not complete the study — 13 in the methotrexate group and 11 in the dactinomycin group. The reported data shows that, for the main hormone measurement, 57 out of 120 participants in the methotrexate group and 76 out of 120 in the dactinomycin group achieved what the trial defined as a "complete response" — meaning their hCG level returned to normal and stayed there across four weekly measurements. The reported data also shows that 48 participants in the methotrexate group and 29 in the dactinomycin group did not have this outcome, and 2 and 4 participants respectively were recorded in a separate category (the specific label for this category was not detailed in the submitted data). Regarding side effects graded as serious (grade 3 or higher on a standard medical scale, meaning more severe), 14 out of 120 participants in the methotrexate group and 20 out of 120 in the dactinomycin group were reported to have experienced at least one such event. For the secondary measure, 72 out of the enrolled participants showed a decline in their hCG level on the very first day of treatment, though a group-by-group breakdown for this figure 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.
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NCT01210222 · results posted 29 November 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called trebananib in a single group of 35 participants. Three people did not complete the trial, leaving 32 who finished. The trial was measuring three main things: how many participants went at least six months without their disease getting worse, how many participants' tumours shrank by a meaningful amount, and what kinds of side effects (unwanted reactions) were recorded. It also tracked two additional things: how long participants lived overall, and how long they went before their disease progressed or they passed away. The reported data shows that 18.8% of participants — roughly fewer than 1 in 5 — went at least six months without their disease getting worse. When it came to tumour shrinkage, only 3.1% of participants showed a meaningful reduction in tumour size (classified as a complete or partial response). For side effects, the reported data shows participants were grouped by severity on a standard scale from Grade 0 (no side effect) to Grade 5 (most severe). The data was not reported in a way that allows a straightforward total summary, but no participants were recorded in the most severe categories (Grade 4 or Grade 5). For the two additional measures, the reported median overall survival — that is, the midpoint of how long participants lived from entering the study — was 6.6 months. The reported median time before disease worsened or death occurred was 2.0 months. (A "median" means that half the participants fell above this figure and half fell below it.) 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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NCT00542490 · results posted 27 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 23 participants, all of whom received a treatment called vaginal cuff brachytherapy (a type of internal radiation directed at the top of the vagina after surgery). Of the 23 who started, 21 completed the trial and 2 did not. The trial was looking at two things: how many participants were free from their cancer progressing (getting worse or spreading) after two years, and how many experienced at least one side effect related to the treatment, which also involved chemotherapy drugs called carboplatin and paclitaxel. The reported data shows that out of the 21 participants who completed the study, 19 were recorded as having progression-free survival at the two-year mark — meaning their cancer had not progressed during that period, based on the study's measurements. For the secondary outcome, the reported data shows that all 23 participants who started the trial experienced at least one side effect that was considered related to the treatment. The data does not break down what types of side effects occurred or how serious they were, so further detail on that point was not reported in this summary. 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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NCT01388907 · results posted 17 November 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 33 in the Prevadh™ group and 28 in the Ringer Lactate™ group. Two participants in the Prevadh™ group did not complete the trial, while all 28 in the comparison group did. The trial was looking at whether a gel product (Prevadh™) compared to a standard fluid (Ringer Lactate™) was associated with differences in the formation of adhesions — internal scar tissue that can form after surgery — following a type of uterine surgery called myomectomy (removal of fibroids). A follow-up keyhole procedure was carried out 10 to 20 weeks after surgery to check for these adhesions. The reported data shows that, for the main outcome, 12 out of 31 participants in the Prevadh™ group were recorded as having adhesions on their uterine scars, compared with 24 out of 28 in the Ringer Lactate™ group. For the secondary outcomes, two different scoring systems were used to measure adhesions in other areas of the pelvis and abdomen — both scored from 0 (no adhesions) to higher numbers (more adhesions). The reported data shows average scores of 4.0 (Prevadh™) versus 6.3 (Ringer Lactate™) on one scale, and 1.6 versus 2.4 on the other. Regarding fertility tracked over three years, the reported data shows 14 pregnancies in the Prevadh™ group and 4 in the Ringer Lactate™ group, with 11 and 3 deliveries respectively, though the data does not include further detail about how these figures were calculated or adjusted. 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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NCT00483327 · results posted 1 July 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom received a hormone medication called Megestrol Acetate. The trial was looking at how uterine tissue responded to this treatment in women with early-stage uterine (endometrial) abnormalities who wanted to avoid surgery — for example, women who hoped to preserve their fertility. Twenty of the 30 participants completed the study, and 10 did not finish. The reported data shows that tissue samples (biopsies) were used to measure how participants' uterine lining changed during treatment. Out of the participants evaluated, 17 were recorded as having a complete response (meaning their tissue sample looked normal or near-normal), 4 had a partial response (tissue moved at least one step toward normal), 6 had stable disease (no change), 1 had progressive disease (tissue moved toward a more concerning state), and 2 participants were listed in an additional category, though specific details on that category were not described further in the submitted data. Regarding side effects, the reported data shows that some participants experienced treatment-related adverse events: 9 had mild-to-moderate effects in one category, with smaller numbers reported across several other categories; 2 participants experienced a more significant (Grade 3) side effect in one category, and 1 experienced a Grade 3 effect in another. For the "Duration of Response" outcome, no numerical data was reported. The trial also recorded that 3 participants became pregnant during or after 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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NCT01251354 · results posted 2 September 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom received the study treatment BN83495. The trial was measuring how the treatment affected tumours in this small group of patients — specifically looking at whether tumours shrank, stayed stable, or grew over time. None of the 6 participants completed the study, meaning all 6 left before the trial finished, though the reasons for this are not detailed in the reported data. The reported data shows that no numerical results were provided for the primary outcome — which was intended to measure how many participants experienced a meaningful response to treatment (including tumour disappearance, shrinkage, or stable disease lasting at least 12 weeks). Similarly, the data was not reported for several secondary outcomes, including time until the tumour grew, how long participants lived without their disease progressing, the proportion who had a measurable tumour response, and how long any response lasted. The only secondary outcome with a number recorded was the count of participants who experienced adverse events (unwanted or unexpected health changes during the trial), which was reported as all 6 participants. Because none of the 6 participants completed the study and most outcome figures were not reported, the available data is very limited and does not allow for any conclusions about the treatment's effects to be drawn from 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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NCT01420081 · results posted 19 May 2015
According to the results reported on ClinicalTrials.gov, this trial looked at two investigational medicines — PF-04691502 and PF-05212384 — in people with cancer whose tumours were grouped by a biological characteristic called PI3K pathway activation (essentially, whether a particular cellular signalling pathway was switched on or not). A total of 67 participants took part across nine different treatment and dose groups. The trial was mainly measuring something called "clinical benefit response" — whether a participant's cancer completely disappeared, shrank significantly, or stayed stable for at least 16 weeks. Importantly, the sponsor (Pfizer) stopped enrolment into the PF-04691502 arm of the study in October 2012, and no formal analysis of that medicine's results was completed. The reported data shows that for PF-05212384, roughly 52.6% of participants in the "PI3K Basal" group (where the pathway was less active) and 26.3% in the "PI3K Activated" group met the clinical benefit response definition; across both groups combined, that figure was approximately 39.5%. When looking only at participants whose tumours shrank noticeably (called "objective response"), the reported figures were around 21.1% for the Basal group, 15.8% for the Activated group, and 18.4% combined. The reported data also shows that the median time before the cancer progressed or a participant died (called "progression-free survival") was 112 days in the Basal group, 89 days in the Activated group, and 108 days across both groups combined. For PF-04691502, because formal analysis was not performed, the numbers listed for that medicine should be interpreted with caution and no conclusions were drawn by the study team. Notably, the reported data shows that zero participants in any group were recorded as having "completed" the study — all participants were listed under "not completed," though the data does not explain the individual reasons for each 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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NCT01289041 · results posted 10 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total, all grouped together under a single "All Patients" category. The trial was measuring how well a treatment performed in people with a particular biological feature in their tumour — specifically, whether a cellular signalling pathway called PI3K was "activated" (switched on) or "non-activated" (not switched on). Participants were placed into one of two subgroups based on this feature: 49 with an activated PI3K pathway and 21 with a non-activated PI3K pathway. The trial tracked how tumours responded to treatment, how long it was before the disease got worse, and how long patients lived overall. The reported data shows that out of 70 participants, only 1 person overall showed a measurable response to treatment — specifically, 1 participant in the activated PI3K group had a complete response (all target areas of cancer disappeared) and 1 participant in the non-activated PI3K group had a partial response (tumour shrank by 30% or more), giving 1 overall responder in each subgroup and 1 total when counted across all patients (noting the figures as submitted reflect this breakdown). An additional 26 participants across all patients were recorded as having stable disease — meaning their cancer neither shrank significantly nor grew during that period. For progression-free survival — the length of time before the disease worsened or a patient died — the reported median figure was 1.9 months across all three groups. For overall survival — the length of time from the start of treatment until death from any cause — the reported median was 8.9 months for the activated PI3K group, 14.2 months for the non-activated PI3K group, and 9.9 months across all patients. It is also noted that the trial recorded zero participants as having formally "completed" the study, 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.
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NCT00937950 · results posted 15 January 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00937950) enrolled 2,003 participants in a single study group. A total of 1,787 people completed the study, while 216 did not finish. The trial was a follow-up study that tracked women over up to four years, measuring things like the presence of certain strains of the human papillomavirus (HPV) in cervical samples, the results of cervical smear tests (Pap tests), whether participants were referred for further examination (colposcopy — a closer look at the cervix), and the results of cervical tissue biopsies taken at 12, 24, and 36 months. The reported data shows that, when looking at HPV DNA detected in cervical samples across different time points, the numbers of participants testing positive varied — for example, at one time point 615 participants were counted in the measurement, at another 444, and at another 255. For cervical smear (Pap test) results, the reported data shows that across the follow-up visits, 1,193 participants had a normal result recorded at one time point, while smaller numbers had various abnormal readings — for instance, 154 with a minor cell change called ASC-US, 100 with low-grade changes (LSIL), and 8 with high-grade changes (HSIL). For cervical biopsies, at the 12-month check 181 participants had a negative result, while others had findings graded as CIN1, CIN2, or CIN3 (these are graded levels of cell changes in the cervix, with grade 3 being the most significant). At 24 and 36 months, the numbers of participants undergoing biopsy were smaller, with similar categories reported. Note that because the same participant could be counted at multiple time points, the numbers across visits cannot simply be added together. 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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NCT00012012 · results posted 7 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total across two groups. The first group of 27 participants received radiation therapy combined with a chemotherapy drug called cisplatin. The second group of 18 participants received the same radiation and cisplatin, plus an additional drug called amifostine. The trial was looking at how often participants experienced serious side effects (graded 3 or 4 out of 4 in severity) during treatment, to understand whether adding amifostine might reduce those side effects compared to radiation and cisplatin alone. The reported data shows that in the first group (radiation plus cisplatin), 81% of participants experienced at least one serious side effect of this kind. In the second group (radiation plus cisplatin and amifostine), 13 out of the 15 participants who completed the study experienced a serious side effect of this kind. The trial had set a threshold — if 8 or fewer participants in the second group had these serious side effects, it would suggest that amifostine reduced them by at least 40%. The reported figure of 13 did not meet that threshold. Two secondary outcomes — tumour control in the pelvic area and spread of cancer to other parts of the body — were listed as planned measures, but no results data for these outcomes was reported 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01069120 · results posted 21 August 2014
According to the results reported on ClinicalTrials.gov, this trial involved 27 participants who were all placed in a single group receiving a treatment called Proellex®. The trial was designed to measure how often participants experienced adverse events (unwanted or unexpected health occurrences) and serious adverse events (more significant health occurrences) while taking the study medication. The reported data shows that none of the 27 participants completed the trial — all 27 were recorded as "not completed." Regarding the primary outcome — tracking the rate of adverse events and serious adverse events across two dosage groups (25 mg and 50 mg Proellex®) — no numerical results were submitted or made available in the data reported to ClinicalTrials.gov. Because the trial did not reach completion and the outcome measurement data was not reported, it is not possible to describe what those figures were. It is worth noting that when a trial ends early and results are not fully reported, this means there is simply no information available from this study to draw on. 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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NCT00499031 · results posted 24 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 people, all of whom received the treatment cetuximab. Thirty-five participants completed the study, while three did not finish. The trial was measuring two main things: how many participants went six months or more without their disease getting worse (known as "progression-free survival"), and how tumours responded to the treatment based on a standard set of measurement rules called RECIST. The reported data shows that, of the 38 participants, 30 went six months or more without their disease progressing, while 5 did not reach that milestone (the remaining figures were not broken down further in the submitted data). For tumour response, the reported data shows that 11 participants had their tumours shrink or disappear to a degree that met the trial's response criteria, 23 participants had disease that was recorded as stable (meaning it neither shrank enough to count as a response nor grew enough to count as progression), and 1 participant's disease was recorded as getting worse within the measurement period. The trial also planned to look at secondary outcomes — including how long responses lasted, how long people survived overall, and the frequency and severity of side effects — however, no numbers for these secondary outcomes were reported 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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NCT00541970 · results posted 17 April 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00541970) enrolled 960 participants across four groups, all receiving different schedules of the HPV vaccine Cervarix or a placebo, with some groups later receiving additional doses. The trial followed participants over five years (up to 60 months). It was measuring levels of antibodies — the body's immune response proteins — against two strains of human papillomavirus (HPV-16 and HPV-18), as well as tracking local symptoms (such as pain, redness, and swelling at the injection site) and general symptoms (such as fatigue, headache, and fever) after vaccination. The reported data shows that antibody levels, measured in laboratory units (EL.U/mL), varied across groups and time points. For example, at the primary measurement point, the group that received Cervarix on a standard three-dose schedule (Cervarix 2 Group) had reported antibody levels of 13,045 units for HPV-16 and 5,087 units for HPV-18. Groups that received fewer initial doses but were later given additional doses (the "Placebo/Cervarix" groups) showed higher antibody levels after those later doses compared to before them. When results were broken down by age at first vaccination (9–14, 15–19, and 20–25 years), antibody levels were generally reported as higher in the younger age groups across all schedules. By the later time points (months 36–60), around 160–180 participants per group were still completing check-ins, meaning some participants had left the study over time. The reported data also shows that, looking at local symptoms across all groups, between 222 and 225 participants reported experiencing any pain, redness, or swelling at the injection site, with 18 to 35 participants per group reporting more severe symptoms (those that prevented normal activity or exceeded 50mm in size). For general symptoms such as headache or fatigue, between 39 and 57 participants per group reported any such symptom, and between 35 and 43 reported symptoms judged by investigators to be possibly related to vaccination; very few (0–4 per group) reported severe general symptoms. 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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NCT00883116 · results posted 14 March 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00883116) enrolled 248 people in each group — one group received a medicine called ixabepilone given through a drip into a vein, and the other group received a standard chemotherapy medicine (either paclitaxel or doxorubicin). The trial was primarily measuring how long participants lived overall, and also tracked how long it was before their cancer got worse, how many participants' tumours shrank, and what unwanted medical events occurred. The reported data shows that for overall survival — the time from joining the trial until death — the ixabepilone group had a reported median (the midpoint value, where half of participants lived longer and half lived shorter) of 10.9 months, compared with 12.3 months in the control chemotherapy group. For progression-free survival — the time until the cancer was recorded as getting worse — the reported median was 3.4 months in the ixabepilone group and 4.0 months in the control group. The reported rate of participants whose tumours shrank (either partially or completely) was 15.2% in the ixabepilone group and 15.7% in the control group. The reported data also shows that serious unwanted medical events occurred in 89 participants in the ixabepilone group and 70 in the control group. Events considered related to the study drug were reported in 43 versus 29 participants respectively. Deaths during the study period were recorded for 121 participants in the ixabepilone group and 95 in the control group. Nerve-related side effects (peripheral neuropathy — tingling, numbness or pain in the hands or feet) were recorded in 223 ixabepilone participants and 215 control participants. Severe or life-threatening unwanted events (Grade 3 or higher) were reported in 49 versus 37 participants, and events considered related to the study drug in 108 versus 62 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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NCT01005329 · results posted 24 February 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01005329) enrolled 34 people who received a combination of chemotherapy and radiation therapy delivered using a technique called IMRT (Intensity-Modulated Radiation Therapy). Thirty of the 34 participants completed the study, while four did not. The trial was primarily measuring how many participants experienced severe treatment-related side effects — specifically those rated "Grade 3 or above" (meaning severe, life-threatening, or fatal) that were not related to blood counts — within the first 90 days of starting treatment. The reported data shows that 23.3% of participants (roughly 7 out of 30) experienced at least one severe non-blood-related treatment side effect within those first 90 days. When the same type of side effects were tracked over a full year, the reported figure rose to 43.3% of participants. The trial also looked at survival and disease outcomes at two years. The reported two-year overall survival rate (the proportion of participants still alive at two years) was 96.7%, and the reported two-year disease-free survival rate (the proportion of participants with no sign of cancer returning and still alive) was 79.1%. The reported rate of cancer returning in the pelvic region within two years was 0%. The reported data also broke down the worst individual side effects experienced per person across severity grades, though the specific labels for each grade category were not included in the submitted data. These figures were reported for 30 participants across six grade categories, with counts of 1, 0, 8, 12, 9, and 0 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00003377 · results posted 4 February 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two chemotherapy medicines — paclitaxel and cisplatin — in people with cancer. The first part of the trial (Phase I) enrolled 12 participants across four dose groups (3 people in each), with the goal of finding a safe and workable dose level by looking at serious side effects or significant delays in treatment. The second part (Phase II) then enrolled 17 participants at the chosen dose level, with 16 of them completing that phase. In total, 29 people took part across both phases of the trial. The reported data shows that in the Phase I dose-finding part, 2 out of 3 participants in each of the two higher-dose groups experienced what the trial defined as a "dose limiting toxicity or significant dose delay" — meaning a serious enough reaction, or a long enough delay in receiving treatment, that it was flagged as a concern at that dose level. The lower dose groups and the Phase II group each reported either zero or one such event. For the 20 participants treated at the recommended dose level across both phases, the reported data shows two further measurements taken at the two-year mark. The estimated probability of being alive and free of disease progression at 24 months was reported as 0.65 (roughly 65 in 100 participants). The estimated probability of simply being alive at 24 months was reported as 0.80 (roughly 80 in 100 participants). These are statistical estimates, not exact counts, and the data notes there is a range of uncertainty around both figures. 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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NCT00303823 · results posted 17 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 98 women in total — 50 in the group receiving Polyphenon E (a defined green tea catechin extract) and 48 in the placebo group. The trial was measuring how participants' cervical disease responded over time, specifically looking at whether a cancer-associated virus called HPV (human papillomavirus) cleared from the body and whether related cervical cell changes improved, stayed the same, or got worse. By the end of the study, 35 of the 50 women in the Polyphenon E group and 38 of the 48 women in the placebo group completed the trial. The reported data shows four possible outcomes were tracked. For a "complete response" — meaning the HPV virus cleared and all signs of cervical cell changes resolved — 7 participants in the Polyphenon E group and 6 in the placebo group were reported to have reached this outcome. For a "partial response" — meaning HPV cleared but some low-grade cervical cell changes remained — 1 participant in the Polyphenon E group and 6 in the placebo group were recorded. The reported data shows that the most common outcome in both groups was "no response" — meaning HPV persisted, with or without low-grade cervical changes — with 27 participants in the Polyphenon E group and 26 in the placebo group falling into this category. Finally, for "progression" — meaning HPV persisted alongside worsening cervical cell changes or signs of invasive cancer — 6 participants in the Polyphenon E group and 3 in the placebo group were reported in this category. 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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NCT00128661 · results posted 2 May 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 7,466 participants in total — 3,727 in the Cervarix group (an HPV vaccine) and 3,739 in the Havrix group (a hepatitis A vaccine used for comparison). The trial was measuring whether Cervarix reduced the number of cases of a pre-cancerous cervical cell change called CIN2+ (a grading used by doctors to describe abnormal cells on the cervix) linked to two strains of the human papillomavirus (HPV), known as HPV16 and HPV18. It also tracked new HPV16/18 infections, long-lasting infections, and how the body's immune system responded to the vaccine. Around 3,453–3,481 participants completed the study across the two groups. The reported data shows that for the primary outcome — confirmed CIN2+ cases associated with HPV16 and/or HPV18 — 1 case was recorded in the Cervarix group compared with 9 cases in the Havrix group. For secondary outcomes, new cervical infections with HPV16 or HPV18 were recorded as 78 events in the Cervarix group versus 387 in the Havrix group. Long-lasting infections (detected over approximately 12 months) numbered 10 in the Cervarix group compared with 104 in the Havrix group. The reported data also shows that a subgroup of 600 participants had their immune response measured using antibody levels (a measure of how the body responds to a vaccine). Before vaccination, antibody levels in both groups were similarly low; after vaccination, the Cervarix group showed notably higher antibody readings for both HPV16 and HPV18 compared to the Havrix group, where levels remained low throughout. 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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NCT00584909 · results posted 29 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom received a combination of two chemotherapy medicines — paclitaxel and carboplatin. Nine participants completed the study, while four did not finish. The trial was measuring two things: how long participants lived without any signs of their disease returning (called "disease-free survival"), and how many participants experienced side effects from the treatment combination. The reported data shows that the median disease-free survival — meaning the midpoint figure for how long participants went without evidence of disease — was 50.5 months. In other words, looking at all participants together, the middle value for time spent disease-free was just over four years. For the secondary outcome, the reported data shows that 9 out of the 13 participants experienced some form of side effects (toxicity) as measured by a standard grading tool used in cancer research. No further breakdown of the types or severity of those side effects was provided in the submitted results. It is worth noting that this was a small trial with only 13 participants, and the results as submitted reflect that limited 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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NCT00294047 · results posted 27 March 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00294047) looked at the Cervarix HPV vaccine compared with an aluminium hydroxide comparison injection (used as a control). The trial was measuring how many participants developed a lasting infection with HPV-16 or HPV-18 (two strains of the human papillomavirus linked to cervical cancer) and/or certain types of abnormal cervical cell changes, known as CIN (cervical intraepithelial neoplasia). Around 2,881 people started in the Cervarix group and 2,871 in the comparison group. Participants were followed up for up to 84 months (seven years), with roughly 1,904 and 1,881 respectively completing that longer follow-up period. The reported data shows that across the various ways the trial defined and measured lasting HPV-16 or HPV-18 infection and related cervical cell changes, fewer participants in the Cervarix group had these outcomes recorded compared with the comparison group. For example, looking at one of the main measures at the earlier time point (Month 48), 7 participants in the Cervarix group and 36 in the comparison group were recorded as having a lasting HPV-16 or HPV-18 infection and/or associated cervical cell changes. At the later time point (Month 84), the reported data shows 7 participants in the Cervarix group and 71 in the comparison group with similar findings. For the secondary measure tracking lasting infection over a 12-month definition period, 2 participants in the Cervarix group and 18 in the comparison group were recorded with lasting HPV-16 or HPV-18 infection. These numbers varied slightly depending on which specific analysis method and participant subgroup was used, but the general pattern of reported counts was consistent across those different approaches. 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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NCT00628901 · results posted 22 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in each group — who had uterine fibroids (non-cancerous growths in the womb). Each group received a different type of tiny bead (called microspheres) injected into the blood vessels feeding the fibroids, with the aim of blocking the blood supply to them. One group received Contour SE Microspheres and the other received Embosphere Microspheres. Most participants completed the study: 27 out of 30 in the Contour SE group and 29 out of 30 in the Embosphere group. The reported data shows that the main thing being measured was how many participants showed a blocked blood supply to their fibroids, confirmed by a special type of MRI scan using a dye injected into a vein. Both groups reported the same number — 29 out of their respective participants showed this result. For the additional measurements, participants were asked to rate their worst level of nausea and pain on a 0–10 scale (where 0 means none and 10 means the worst imaginable). The Contour SE group reported average scores of 5.5 for nausea and 6.0 for pain, while the Embosphere group reported 4.8 for nausea and 5.6 for pain. The reported data also shows that the time participants spent under X-ray guidance during the procedure averaged 31.1 minutes for the Contour SE group and 24.9 minutes for the Embosphere group, and the overall procedure time averaged 102 minutes versus 95.6 minutes respectively. The reported data also notes that adverse events (unwanted medical occurrences recorded by the investigators during follow-up) totalled 68 events in the Contour SE group and 58 events in the Embosphere group; the breakdown of what those events were is not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00258362 · results posted 11 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people who had been diagnosed with endometrial cancer (cancer of the lining of the uterus). All 41 participants completed the study. The trial was measuring two main things over time: how many patients remained free of their cancer progressing (getting worse or spreading) and were still alive, and separately, how many patients were still alive overall. The reported data shows that, at three different points in time during follow-up, the estimated percentage of patients whose cancer had not progressed and who were still alive was 86%, then 76%, and then 68%. These figures were calculated using a standard statistical method called Kaplan-Meier, which is a way of estimating survival or disease-free rates across a group over time. It is worth noting that the specific time points these percentages correspond to were not clearly identified in the data as submitted. For the second measurement — the percentage of patients still alive overall — the reported data shows estimated figures of 94%, then 91%, and then 80% at those same three time points. Again, the exact time points were not specified in the submitted data. No other outcome figures were 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.
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NCT00136955 · results posted 25 June 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people who received a combination of two chemotherapy medicines, irinotecan and cisplatin. The trial was measuring how tumours responded to this treatment, using a standard set of measurement rules called RECIST (which involves tracking whether tumours shrink, stay the same, or grow). Of the 41 people who started, 18 completed the study and 23 did not complete it. The trial also tracked how long people lived overall and how long it took before their disease progressed (got worse). The reported data shows that, looking at all 41 participants (the "intent-to-treat" group), 8 people had a complete response (no detectable tumour), 8 had a partial response (tumour shrank), 13 had stable disease (tumour neither shrank significantly nor grew), 8 had progressive disease (tumour grew), and 4 were recorded as not assessable, with 16 participants counted as having some form of response overall. Among only those participants who could be fully evaluated (32 people), the reported figures were 8 complete responses, 7 partial responses, 11 stable disease, 6 progressive disease, and 15 counted as responders. For survival, the reported data shows that in the fully evaluable group, the median overall survival — meaning the point at which half the participants had passed away — was 652 days, and the median time to tumour progression was 277 days. In the full 41-person group, the reported median overall survival was 448 days and median time to tumour progression was 263 days. 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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NCT00191100 · results posted 25 May 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 515 people in total — 259 in a group receiving gemcitabine, cisplatin, and radiation, and 256 in a group receiving cisplatin and radiation alone. The trial was measuring how long participants went without their disease getting worse or dying (called progression-free survival), as well as other outcomes such as overall survival, tumour response, and the rate at which the disease progressed locally (in the cervix or pelvis). The reported data shows that at three years, 149 participants in the gemcitabine/cisplatin/radiation group had experienced disease progression or death from any cause, compared with 141 in the cisplatin/radiation group; at that same point, 55 participants in the first group and 83 in the second were still progression-free and being followed up. For the secondary outcome looking at local disease progression, the reported proportion was 0.113 (roughly 11 in every 100 participants) in the gemcitabine/cisplatin/radiation group and 0.166 (roughly 17 in every 100) in the cisplatin/radiation group. For tumour response, 223 participants in the first group and 217 in the second were reported as having a confirmed response. The reported data also shows death counts tracked over various time points, with 22 deaths recorded in the gemcitabine/cisplatin/radiation group and 25 in the cisplatin/radiation group at the latest reported time point; the median time to progression was not reached during the study period and so could not be reported as a single figure. 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.