This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma (NCT01012297), a randomized phase 3 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01012297 |
| Phase | Phase 3 |
| Condition | Recurrent Uterine Corpus Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 107 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Participants had recurrent or advanced uterine leiomyosarcoma. The listed conditions also include recurrent uterine corpus sarcoma and stages IIIA, IIIB, IIIC, IVA, and IVB uterine sarcoma. The primary endpoint population is described as all randomized participants.
Intervention
One arm received gemcitabine hydrochloride and docetaxel with bevacizumab. Filgrastim or pegfilgrastim was also used. Bevacizumab was administered intravenously on day 1; the chemotherapy and growth-factor schedules are described in the registry record.
Comparator
The comparison arm received gemcitabine hydrochloride and docetaxel with placebo, along with filgrastim or pegfilgrastim. The registry describes placebo administration intravenously on day 1 and the same chemotherapy schedule as in the bevacizumab arm.
Primary question
The central question was whether progression-free survival differed between the randomized groups. Progression-free survival was defined as time from study entry to documented disease progression or death from any cause, with censoring for participants alive and disease free at last follow-up. The registry record reports arm-specific median estimates and confidence intervals, but a formal between-arm estimate is not reported in the registry record.
This is a question about the comparative pattern of outcomes under two treatment strategies, not simply whether either group had a particular median. Randomization supports a comparison between assigned groups, while the interpretation still depends on the completeness and analysis of follow-up. The registry record identifies the study as randomized and parallel, with no masking. It reports an enrollment of 107 participants. The endpoint description specifies assessment with a log-rank test stratified by prior whole pelvic radiotherapy, but the registry record does not report a test result or a hazard ratio. The posted median estimates therefore describe each arm; on their own, they do not establish the size or statistical uncertainty of a relative treatment effect.
3. Trial Design
The registry record describes a randomized, phase III, parallel-group trial with no masking. It enrolled 107 participants and compared two regimens for recurrent or advanced uterine leiomyosarcoma. In Arm I, participants received gemcitabine hydrochloride and docetaxel with placebo. In Arm II, participants received the same chemotherapy with bevacizumab. Both arms also included filgrastim or pegfilgrastim. The record names the National Cancer Institute as sponsor.
The planned primary outcome was progression-free survival, assessed from randomization until documented progression or death from any cause. The stated timeframe was up to 60 months. The registry’s endpoint description also defines the interval as running from study enrollment to progression or death, and says that participants alive and disease free at last follow-up were censored at the date of their last CT scan. The analysis description specifies a log-rank test stratified by whether participants had whole pelvic radiotherapy before study treatment, and use of the product-limit method to estimate the cumulative distribution of progression-free survival in each group.
The record lists overall survival, adverse effects, and objective response rate as secondary outcomes. It reports objective response rate results, while the other posted information includes adverse-event counts. Inferential results for overall survival are not reported in the registry record. The trial status is terminated. A reason for termination, detailed accrual history, and further operational context are not reported in the registry record. The record gives a start date of 2009-11 and primary completion of 2015-09; these dates alone do not explain why the study ended or establish whether its planned analysis was completed.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Arm I Gem+Doce+Placebo | Arm II Gem+Doce+Bev |
|---|---|---|
| STARTED | 54 | 53 |
| COMPLETED | 54 | 53 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Arm I Gem+Doce+Placebo | Arm II Gem+Doce+Bev | Total |
|---|---|---|---|---|
| Participants analysed | 54 | 53 | 107 | |
| Age, Continuous | years | 57.5 (SD 8.1) | 54.0 (SD 8.7) | 55.7 (SD 8.6) |
| Age, Customized: Age Groups – 20-29 years | Participants | 0 | 1 | 1 |
| Age, Customized: Age Groups – 30-39 years | Participants | 0 | 3 | 3 |
| Age, Customized: Age Groups – 40-49 years | Participants | 11 | 12 | 23 |
| Age, Customized: Age Groups – 50-59 years | Participants | 24 | 25 | 49 |
| Age, Customized: Age Groups – 60-69 years | Participants | 19 | 12 | 31 |
| Sex: Female, Male: Female | Participants | 54 | 53 | 107 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 3 | 7 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 | 43 | 91 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 7 | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 12 | 18 |
| Race (NIH/OMB): White | Participants | 46 | 36 | 82 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 4 |
| Prior whole pelvic radiation: Yes | Participants | 11 | 11 | 22 |
| Prior whole pelvic radiation: No | Participants | 43 | 42 | 85 |
| Performance Status: 0: Asymptomatic | Participants | 38 | 41 | 79 |
| Performance Status: 1: Symptomatic, fully ambulatory | Participants | 15 | 11 | 26 |
| Performance Status: 2: Symptomatic, in bed < 50% of time | Participants | 1 | 1 | 2 |
| FIGO Stage: 1 | Participants | 20 | 11 | 31 |
| FIGO Stage: 2 | Participants | 4 | 0 | 4 |
| FIGO Stage: 3 | Participants | 3 | 5 | 8 |
| FIGO Stage: 4 | Participants | 22 | 30 | 52 |
| FIGO Stage: unknown | Participants | 5 | 7 | 12 |
| Cell Type: Leiomyosarcoma | Participants | 52 | 52 | 104 |
| Cell Type: Sarcoma, Unsp. | Participants | 1 | 0 | 1 |
| Cell Type: Carcinsarcoma | Participants | 0 | 1 | 1 |
| Cell Type: Unknown | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from a defined starting point until the first of disease progression or death from any cause. It combines these events into one time-to-event outcome, so a participant’s time is counted until progression or death, while a participant who is alive and has no documented progression at last follow-up is censored at that follow-up point. The registry specifies censoring at the date of the last CT scan for participants alive and disease free.
This endpoint is used in clinical trials because it captures how long participants remain alive without documented progression, rather than counting only whether progression occurred by a fixed assessment date. Time-to-event methods can account for participants whose follow-up ends before an event is observed. In general, that approach depends on sufficiently complete follow-up and appropriate handling of censoring; censoring is not itself evidence that an event did or did not occur later.
The registry gives a timeframe of up to 60 months and describes the population as all randomized participants. Its endpoint text refers to the interval between study enrollment and progression or death, while the timeframe refers to randomization as the starting point. The registry record does not clarify this wording difference. The reported arm-specific medians describe the point at which the estimated event-time distribution reaches its midpoint. They do not summarize every participant’s experience, and the confidence intervals express uncertainty around each median rather than directly estimating the difference between arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome estimates a median progression-free survival of 6.2 months for Arm I, gemcitabine and docetaxel with placebo, with a 95% confidence interval from 2.9 to 9.9 months. For Arm II, gemcitabine and docetaxel with bevacizumab, the median is 4.2 months, with a 95% confidence interval from 3.1 to 8.4 months. These are arm-specific summaries. They do not by themselves provide a formal estimate of the relative difference between treatment groups.
The confidence intervals are broad and overlap. In general, a confidence interval describes uncertainty in an estimate under the method used to construct it. Comparing whether two separate confidence intervals overlap is not a substitute for a direct treatment comparison: a formal comparison uses the trial’s time-to-event data and its specified analysis. The registry describes a stratified log-rank test and product-limit estimates, but the test result and a hazard ratio are not reported in the registry record. The registry record also does not report an analysis count for the primary comparison. As a result, the posted medians do not establish whether the arms differed statistically or quantify a relative effect.
The arm sizes were 54 and 53 participants, respectively. These are the numbers shown for the endpoint groups, not a guarantee that every participant contributed the same duration of follow-up or had an observed progression or death. The registry’s endpoint definition allows censoring at the last CT scan. The number and timing of events, follow-up distribution, and details of missing observations are not reported in the registry record. Those details matter for understanding how much information supports the median estimates.
The secondary response outcome reports an objective response rate of 31.5% in Arm I and 35.8% in Arm II, each with a 95% confidence interval. The unadjusted recalculation for the response comparison reports a risk difference of 0.044, with a 95% confidence interval from -0.135 to 0.223 and p = 0.633. This is a simple unadjusted comparison of the posted response counts, not a replacement for a sponsor’s prespecified analysis. No discrepancy is flagged for this recalculation. The response result is not the primary time-to-event outcome and should not be treated as a substitute for an unreported primary comparison.
Overall, the registry record permits descriptive reading of the arm-specific primary estimates and the posted response outcome, but it leaves key inferential details unavailable. A reader should distinguish the medians and their uncertainty from a direct comparison, and should not infer that an absent hazard ratio or test result favors either regimen.
9. Statistical Methods Explained
The primary endpoint is a time-to-event outcome. In general, time-to-event analysis uses both the time until an event and information from participants who have not had an event by the end of their observed follow-up. Participants with no recorded progression or death at last follow-up are censored rather than treated as if they had an event at that time. The registry describes censoring at the last CT scan for participants who were alive and disease free. The number of censored participants and the censoring pattern are not reported in the registry record.
The product-limit method named in the registry is commonly used to estimate the event-free distribution over time while accounting for censoring. Its estimated curve represents the probability of remaining free of the defined event over follow-up, subject to the method’s assumptions. The median is the time at which that estimated distribution reaches its midpoint. A median gives a compact summary, but it does not show the full curve or capture all differences in timing between groups. The registry record reports the medians and their 95% confidence intervals, but the underlying survival curves and event counts are not reported in the registry record.
The registry specifies a log-rank test stratified by whether participants had whole pelvic radiotherapy before starting study treatment. In general, a log-rank test compares the pattern of event times between groups across follow-up. Stratification means that the comparison is organized across levels of a specified factor, rather than ignoring that factor. Here, the stated factor is prior whole pelvic radiotherapy. The registry does not report the stratum counts, the test statistic, or the resulting p-value. A stratified test result therefore cannot be reconstructed from the arm-specific medians and confidence intervals alone.
A hazard ratio is often used to summarize a relative time-to-event contrast between groups. In general, it compares event rates over time under a model and depends on assumptions about how that contrast behaves during follow-up. The registry record does not report a sponsor hazard ratio for progression-free survival. It would not be appropriate to derive one from the two medians: a median is a single point on each estimated distribution, whereas a hazard ratio uses information about event timing across follow-up. The record’s analysis description is not enough to determine a treatment effect estimate or its precision.
The posted confidence intervals describe uncertainty in the arm-specific medians. They are not confidence intervals for the between-arm contrast. In general, an interval conveys a range of values compatible with the data and the statistical method, rather than certainty that the true value lies within that particular realized interval. The overlapping intervals do not establish equivalence, and they do not settle whether a direct comparison would be statistically significant. The direct comparison result is not reported in the registry record.
The response endpoint is binary: each participant is categorized according to whether an objective response was recorded under RECIST 1.1. The posted arm-specific percentages have 95% confidence intervals. A recalculated unadjusted comparison reports a risk difference and its interval, along with p = 0.633. In general, a risk difference expresses the difference between two proportions on the proportion scale. The recalculation uses the posted summary counts and is not an adjusted model or a substitute for a sponsor analysis. No discrepancy is flagged. The registry lists RECIST 1.1 as the response criteria, but further details of response assessment and confirmation are not reported in the registry record.
Planning illustrations based on an observed response effect are not observed trial results and are not observed power. In general, sample-size planning asks how many participants would be needed under specified assumptions to detect a chosen effect with a chosen power and significance level. The registry’s illustration assumes two-sided significance level 0.05, equal allocation, and a normal approximation, and uses specified fractions of the observed effect. It is explicitly not the trial’s own design calculation. Such illustrations are sensitive to the effect chosen: an effect smaller than the observed estimate requires a larger planned sample under otherwise similar assumptions. The displayed planning values should therefore be read as hypothetical requirements under those assumptions, not as evidence about what the trial was designed to detect or the probability that it detected an effect.
For adverse events, counts describe participants with events in each arm, with the listed number at risk serving as the denominator in the registry record. In general, these counts are descriptive safety summaries; without a specified inferential method, follow-up adjustment, or detailed event-level data, they do not provide a complete comparative safety analysis. The registry’s serious-event terms and percentages are also descriptive and should not be interpreted as causal estimates.
Across all these methods, interpretation is limited by the information actually reported. The registry gives the planned primary method but not its result, and it does not report the analysis population details beyond “all randomized” for the primary endpoint. The timing of data cutoff, missing-data handling beyond the censoring description, and any interim analyses are not reported in the registry record. These omissions prevent a full assessment of the analysis implementation and precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes, including progression-free survival, overall survival, adverse effects, and objective response rate. Testing multiple outcomes can increase the chance of obtaining at least one apparently notable result by chance. In general, multiplicity procedures address this issue by controlling how statistical evidence is interpreted across a family of tests, for example through an adjustment or a prespecified order of testing. Whether such procedures were planned or applied is not reported in the registry record.
The objective response comparison is an unadjusted recalculation, with p = 0.633. It should not be treated as if it were adjusted for the other outcomes or as a definitive standalone test. No multiplicity adjustment, hierarchy, or confirmatory status for the secondary outcomes is reported in the registry record. The primary progression-free survival test result is also not reported, so there is no reported primary inference against which the secondary findings can be positioned.
The primary endpoint population is described as all randomized. The record gives arm sizes of 54 and 53 for the primary outcome. It does not describe exclusions after randomization, the handling of protocol deviations, or an alternative analysis population. Those details are not reported in the registry record. The endpoint description says participants alive and disease free at their last follow-up were censored at the date of their last CT scan. Other missing-data rules, including how absent or unevaluable assessments were handled, are not reported in the registry record.
In general, incomplete follow-up and missing assessments can affect the precision and interpretation of time-to-event estimates. Censoring is a standard part of such analyses, but its appropriateness depends on how follow-up ends and how that relates to the event risk. The registry does not report enough information about censoring, loss to follow-up, or data cutoff to assess those patterns. Interim analyses and stopping rules are also not reported in the registry record. The terminated status alone does not establish whether interim monitoring occurred, why the trial ended, or whether termination was related to the results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm I | 17 | 54 | 31.5% |
| Arm II | 21 | 53 | 39.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm I | 51 of 54 |
| Arm II | 51 of 53 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I | Arm II |
|---|---|---|---|
| Lung Infection | Infections and infestations | 3 of 54 | 2 of 53 |
| Thromboembolic Event | Vascular disorders | 2 of 54 | 3 of 53 |
| Platelet Count Decreased | Investigations | 1 of 54 | 3 of 53 |
| Small Intestinal Obstruction | Gastrointestinal disorders | 1 of 54 | 2 of 53 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 54 | 2 of 53 |
| Catheter Related Infection | Infections and infestations | 1 of 54 | 2 of 53 |
| Hyperglycemia | Metabolism and nutrition disorders | 2 of 54 | 1 of 53 |
| Dehydration | Metabolism and nutrition disorders | 2 of 54 | 1 of 53 |
| Fatigue | General disorders | 2 of 54 | 0 of 53 |
| Infections And Infestations - Other | Infections and infestations | 0 of 54 | 2 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I | Arm II |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 47 of 54 | 48 of 53 |
| Fatigue | General disorders | 45 of 54 | 42 of 53 |
| Platelet Count Decreased | Investigations | 39 of 54 | 45 of 53 |
| Alopecia | Skin and subcutaneous tissue disorders | 36 of 54 | 34 of 53 |
| Nausea | Gastrointestinal disorders | 35 of 54 | 29 of 53 |
| White Blood Cell Decreased | Investigations | 28 of 54 | 33 of 53 |
| Neutrophil Count Decreased | Investigations | 26 of 54 | 25 of 53 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 28 of 54 | 23 of 53 |
| Constipation | Gastrointestinal disorders | 24 of 54 | 26 of 53 |
| Diarrhea | Gastrointestinal disorders | 19 of 54 | 22 of 53 |
Serious events with the highest arm-level rate: platelet count decreased (5.7%), thromboembolic event (5.7%), lung infection (5.6%), small intestinal obstruction (3.8%), abdominal pain (3.8%).
The registry reports serious adverse events in 17 of 54 participants in Arm I and 21 of 53 participants in Arm II. It reports other adverse events in 51 participants in each arm, with 54 and 53 participants at risk, respectively. These are counts of participants affected, not event rates adjusted for the length of time each participant was followed. The registry does not report deaths in the adverse-event summary.
The listed serious-event terms include platelet count decreased and thromboembolic event, each reported as 5.7%; lung infection at 5.6%; small intestinal obstruction and abdominal pain, each at 3.8%; and infections and infestations - other at 3.8%. The registry record does not specify the arm attribution for these listed term percentages in the available summary. They should therefore be read as listed serious-event frequencies, not as arm-specific comparative estimates.
In general, adverse-event counts can describe what was recorded, but a fair comparison also depends on event definitions, follow-up duration, exposure, severity grading, and how repeated events are handled. These details are not all reported in the registry record. The counts alone do not establish that one regimen caused more harm, nor do they provide a complete assessment of comparative safety. The listed adverse effects were assessed using CTCAE Version 4.0 according to the registry’s secondary-outcome description.
12. What the Result Does, and Does Not, Mean
The posted primary results describe median progression-free survival within each randomized arm. They provide a useful summary of the recorded time-to-event distributions, with uncertainty around each median. They do not, by themselves, quantify a direct treatment contrast. The registry record does not report the primary log-rank result or a hazard ratio, so the available information does not establish whether progression-free survival differed statistically between the groups.
The response outcome offers another view of the trial, based on RECIST 1.1 objective response. Its unadjusted comparison is imprecise, with a confidence interval for the risk difference extending on both sides of no difference. This result does not answer the time-to-event question, and it does not establish that the regimens are equivalent. A failure to demonstrate a difference is not the same as evidence that the treatments have the same effect.
In general, randomized allocation supports causal interpretation by balancing measured and unmeasured factors on average across groups, but interpretation still depends on trial conduct, follow-up, endpoint assessment, and appropriate analysis. This registry identifies the trial as randomized and unmasked. It does not report enough information to evaluate all aspects of follow-up, missingness, or analysis implementation. The terminating status also cannot be interpreted as a result or as an explanation for the observed estimates; the reason is not reported in the registry record.
The results should not be read as medical advice or as a recommendation for an individual. They describe posted group-level outcomes in this trial population. The registry record does not report a complete primary comparison, does not provide inferential results for every listed secondary outcome, and does not establish a definitive overall benefit-harm balance. Any conclusion about relative effects would require fuller analysis reporting and clinical context beyond these posted summaries.
13. Why This Trial Matters Statistically
This trial illustrates why a pair of arm-specific medians is not enough to answer a comparative time-to-event question. Each median summarizes one estimated distribution, while the treatment question concerns how the groups compare across follow-up. A direct analysis uses event-time information and accounts for censoring; the registry describes a stratified log-rank test and product-limit estimates but does not report the test result or a hazard ratio. The distinction between descriptive estimates and an inferential contrast is central to reading clinical trial results.
It also illustrates the importance of matching an interpretation to the endpoint. Progression-free survival and objective response describe related but different aspects of disease status. The response outcome has a posted unadjusted comparison, but that comparison cannot stand in for the primary endpoint analysis. Multiple outcomes further complicate interpretation: in general, unadjusted secondary tests offer weaker confirmatory evidence when the number of tests and any planned hierarchy are unknown.
The registry’s planning illustration is another useful statistical distinction. A sample-size calculation based on an observed effect is hypothetical and depends on its assumptions. It is not evidence of the trial’s design rationale, and it is not observed power. The registry explicitly describes the illustration as separate from the trial’s own design. This matters because readers can otherwise mistake a post hoc planning exercise for a prespecified target or a measure of how conclusive the completed study was.
Finally, the record demonstrates the value of transparent reporting. The primary estimates and safety counts are available, but the direct primary comparison, several analysis details, and the reason for termination are not reported in the registry record. Those absences limit what can be concluded from the posted results, regardless of how plausible any interpretation may seem.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for statistical interpretation is that the registry reports arm-specific progression-free survival medians but not the formal primary comparison. The log-rank test is described, including stratification by prior whole pelvic radiotherapy, but its result is not reported in the registry record. No hazard ratio is reported. The medians and their confidence intervals cannot substitute for those missing results.
The registry’s time origin is not fully consistent in its wording: the timeframe refers to randomization, while the endpoint description refers to study enrollment. The record does not clarify whether these refer to the same date in the analysis. It also does not report event counts, the distribution of follow-up, the number censored, or the extent of missing endpoint assessments. These omissions make it difficult to assess how much information underlies the median estimates.
The trial is listed as terminated, but the reason for termination is not reported in the registry record. The record does not state whether the planned enrollment was reached, whether the primary analysis was completed, or whether interim monitoring influenced conduct. No explanation should be inferred from status alone. The analysis population is described as all randomized, but exclusions, protocol deviations, and handling of missing data beyond the stated censoring rule are not detailed.
The response comparison is an unadjusted recalculation rather than a reported sponsor analysis. It is one secondary outcome among several, and the registry does not report a multiplicity strategy. The listed serious adverse-event term percentages are not assigned to specific arms in the available summary, limiting arm-level interpretation. The safety counts also do not provide exposure-adjusted comparisons. These trial-specific reporting limits mean that the posted information supports cautious description, not a complete comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma — NCT01012297.
- Registry record last updated 2026-06-24; status last verified 2026-05.
- Results first posted 2017-07-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This randomized, phase III, parallel-group trial compared gemcitabine hydrochloride and docetaxel with bevacizumab against the same chemotherapy with placebo in recurrent or advanced uterine leiomyosarcoma. The registry reports enrollment of 107 participants and identifies the National Cancer Institute as sponsor. The trial is listed as terminated.
The primary outcome was progression-free survival. The registry reports arm-specific median estimates and 95% confidence intervals, but the formal comparison result and hazard ratio are not reported in the registry record. Objective response rate is also reported, with an unadjusted recalculation available; the registry lists overall survival and adverse effects among secondary outcomes. Serious and other adverse-event counts are posted.
The record describes a stratified log-rank approach and product-limit estimation for the primary endpoint. The reason for termination, fuller missing-data details, and multiplicity procedures are not reported in the registry record. Consequently, the posted information supports descriptive interpretation of selected outcomes but not a complete inferential assessment of the primary treatment comparison.