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 Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer (NCT00108745), a randomized phase 3 study. The primary outcome is Overall Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00108745 |
| Phase | Phase 3 |
| Condition | Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1157 |
| Arms in the primary outcome | 3 |
| Lead sponsor | GOG Foundation |
| Results posted | Yes |
2. Clinical Question
Population
Women with stage III or stage IV ovarian, primary peritoneal, or fallopian tube cancer who achieved a complete clinical response to primary platinum/taxane chemotherapy. The registry lists a range of ovarian and fallopian tube histologies and stage categories. The primary outcome population is all randomized participants.
Intervention
One group received paclitaxel poliglumex intravenously on day 1, with treatment repeated every 28 days for up to 12 courses unless disease progression or unacceptable toxicity occurred. A second treatment group received paclitaxel intravenously on day 1, also repeated every 28 days for up to 12 courses unless progression or unacceptable toxicity occurred.
Comparator
The observation group received no further anticancer treatment until evidence of disease progression. This is a comparison of maintenance chemotherapy strategies with observation after response to primary chemotherapy, not a comparison of initial cancer treatment.
Primary question
The primary outcome asks how long participants lived after enrollment, regardless of cause of death. The registry reports median overall survival and 95% confidence intervals for each randomized group. It does not report a hazard ratio or a statistical test comparing the groups, so the posted medians and intervals describe the group results but do not by themselves establish whether the groups differed statistically.
3. Trial Design
This was a randomized, phase III, parallel-group trial with no masking. The registry reports enrollment of 1157. The primary outcome population is all randomized participants. The three reported groups were paclitaxel poliglumex, with 387 participants; paclitaxel, with 384 participants; and observation, with 386 participants. These are the group counts shown for the primary outcome.
Participants had advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer and had achieved a complete clinical response to primary platinum/taxane chemotherapy. The registry lists stage III and stage IV disease, alongside several histological categories. Its brief description frames the study as a comparison of maintenance paclitaxel, polyglutamate paclitaxel, and observation after response to initial treatment.
For the paclitaxel poliglumex group, treatment was given intravenously over 10–20 minutes on day 1 and repeated every 28 days for up to 12 courses, unless progression or unacceptable toxicity occurred. The paclitaxel group received the drug intravenously over 3 hours on day 1, on the same repeat schedule and subject to the same stated stopping conditions. The observation group received no further anticancer treatment until evidence of progression.
Follow-up for overall survival was described as physical exams and histories every three months for the first two years, then every six months for the next three years, and then annually for the next five years. The registry lists a start date of 2005-03-21 and a primary completion date of 2015-02-03. The overall status is recorded as UNKNOWN. Details such as concealment of allocation and the statistical analysis plan are not reported in the registry record.
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 (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) |
|---|---|---|---|
| STARTED | 387 | 384 | 386 |
| COMPLETED | 353 | 349 | 349 |
| NOT COMPLETED | 34 | 35 | 37 |
Reasons for not completing this period:
| Reason | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) |
|---|---|---|---|
| Withdrawal by Subject | 19 | 12 | 12 |
| Never Treated | 8 | 10 | 12 |
| Ineligible | 7 | 13 | 13 |
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.
Population: All enrolled patients.
| Characteristic | Unit | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) | Total |
|---|---|---|---|---|---|
| Participants analysed | 387 | 384 | 386 | 1157 | |
| Age, Continuous | years | 59.02 (SD 10.89) | 58.80 (SD 10.42) | 59.07 (SD 9.68) | 58.96 (SD 10.34) |
| Age, Customized: < 40 years | Participants | 21 | 13 | 11 | 45 |
| Age, Customized: 40 - 49 years | Participants | 54 | 71 | 57 | 182 |
| Age, Customized: 50 - 59 years | Participants | 115 | 114 | 138 | 367 |
| Age, Customized: 60 - 69 years | Participants | 137 | 132 | 126 | 395 |
| Age, Customized: 70 - 79 years | Participants | 56 | 46 | 49 | 151 |
| Age, Customized: >= 80 years | Participants | 4 | 8 | 5 | 17 |
| Sex: Female, Male: Female | Participants | 387 | 384 | 386 | 1157 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 18 | 25 | 16 | 59 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 341 | 338 | 346 | 1025 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 28 | 21 | 24 | 73 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 3 | 1 | 5 |
| Race (NIH/OMB): Asian | Participants | 7 | 11 | 9 | 27 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 1 | 1 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 21 | 13 | 17 | 51 |
| Race (NIH/OMB): White | Participants | 353 | 352 | 355 | 1060 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 4 | 3 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival, measured over All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures the time from study enrollment until death from any cause. The registry reports it in months and summarizes it with the median: the point by which half of the observed survival times are at or below that time and half are at or above it, as estimated by the survival analysis. A median is a description of the timing of events, not a statement about the survival experience of every participant.
Participants still alive at their last follow-up were censored on the date of their last contact. Censoring allows survival analysis to incorporate information from participants whose eventual time of death was not observed during follow-up. It does not mean that their later survival time is known. The registry describes follow-up by scheduled visits over time, but does not report the completeness of follow-up or the amount of missing outcome information.
Overall survival is a time-to-event endpoint that captures deaths from any cause rather than only deaths attributed to the cancer. The registry gives a median and a 95% confidence interval for each group. The reported medians are 60.0 months for paclitaxel poliglumex, 56.8 months for paclitaxel, and 58.3 months for observation. Their respective 95% confidence intervals are 51.7 to 68.6 months, 47.3 to 65.9 months, and 51.9 to 72.5 months. These estimates describe the groups; a direct inferential comparison is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports median overall survival of 60.0 months in the paclitaxel poliglumex group, 56.8 months in the paclitaxel group, and 58.3 months in the observation group. The associated 95% confidence intervals are 51.7 to 68.6 months, 47.3 to 65.9 months, and 51.9 to 72.5 months, respectively. These are group-level estimates of time from enrollment to death from any cause, with participants still alive at last contact censored at that contact.
The intervals overlap. In general, a confidence interval conveys uncertainty around an estimated quantity under the method used to calculate it. It is not a range containing the survival time of every participant, and overlap between intervals is not a substitute for a formal comparison. The registry does not report a hazard ratio, a test statistic, or a p-value for the primary outcome. It also reports no analyses in the posted results. Therefore, the medians and confidence intervals alone cannot establish whether any observed difference between groups is statistically distinguishable from chance under a specified comparison procedure.
The primary endpoint is defined consistently across the groups, and all randomized participants are identified as the outcome population. The reported group counts for this outcome are 387, 384, and 386. The counts describe the analysis listings; they do not show how many participants had complete follow-up at every scheduled visit. The outcome definition accounts for participants alive at last follow-up through censoring, but further details about the censoring distribution, loss to follow-up, or sensitivity analyses are not reported in the registry record.
The clinical question is about maintenance treatment after a complete clinical response to primary platinum/taxane chemotherapy. The observation group is described as receiving no further anticancer treatment until evidence of progression. Thus, the outcome summaries concern the strategies within this particular post-response setting. They should not be read as results for initial treatment, for disease stages or histologies outside those listed, or for other clinical settings.
The registry also lists progression-free survival, adverse effects, patient-reported quality of life, and patient-reported peripheral neuropathy symptoms as secondary outcomes. It does not provide values or comparative analyses for these outcomes in the posted results. Overall survival summaries alone do not describe those other outcomes. The record also does not report an analysis accounting for multiple outcomes or comparisons. No conclusion about treatment benefit, harm, or statistical significance can be drawn from the posted medians alone.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure. Its starting point is study enrollment, and its event is death from any cause. Participants alive at last contact contribute follow-up up to that contact and are censored there. In general, censoring is necessary when the event time is not observed for every participant; it preserves the observed follow-up information without treating a censored participant as though their later event time were known. The registry does not report further details of the survival estimation procedure.
What does the median describe?
For a time-to-event outcome, the median is the estimated time by which half of the population under study has experienced the event. The reported medians are 60.0 months for paclitaxel poliglumex, 56.8 months for paclitaxel, and 58.3 months for observation. They describe the center of each estimated survival distribution. They do not show the full distribution of survival times, the number of participants surviving at a particular later time, or the experience of any individual participant.
In general, time-to-event medians can be estimated while retaining information from participants who have not experienced the event by the time their observation ends. This depends on handling censoring appropriately. The registry states that participants still alive at last follow-up were censored on their last contact date. It does not give details about the number or timing of censoring events, or the method used to estimate the medians.
How should the confidence intervals be read?
The registry reports 95% confidence intervals of 51.7 to 68.6 months for paclitaxel poliglumex, 47.3 to 65.9 months for paclitaxel, and 51.9 to 72.5 months for observation. In general, a confidence interval expresses statistical uncertainty about an estimated parameter under the assumptions and procedure used to construct it. It does not mean that 95% of participants had survival times inside the interval. The registry names the confidence level and interval bounds, but does not report the method used to calculate those intervals.
Confidence intervals for each group are not the same as a confidence interval for a between-group contrast. A direct comparison would require an estimate and inferential procedure for the difference or relative event rate between groups. No hazard ratio, contrast interval, test result, or p-value for overall survival is reported in the registry record. Although the group intervals overlap, that observation is not itself a test of the randomized comparison.
Why does censoring matter?
In general, survival analysis assumes that the censoring process is handled in a way that supports valid estimation. Censoring may occur because a participant is alive at the end of available follow-up or has no further recorded contact. If the reasons for censoring are related to the outcome in ways not addressed by the analysis, estimates may be difficult to interpret. The registry gives the rule for censoring participants alive at last follow-up but does not describe losses to follow-up, reasons for censoring, or analyses examining alternative assumptions.
Scheduled follow-up was described as physical exams and histories every three months for the first two years, every six months for the next three years, and annually for the next five years. A schedule describes planned observation intervals; it does not by itself establish that every participant completed every visit. Completeness and timing of follow-up are not reported in the registry record.
What do planning illustrations represent?
In general, a sample-size planning calculation asks how much information might be needed to detect a specified effect under stated assumptions. The planning illustrations associated with these results are described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was designed using those assumptions, and they are not observed power.
For time-to-event planning, the stated convention is to report the total number of events; the Schoenfeld method is named. For other outcomes, planning quantities are expressed as participants per arm. No planning values or protocol sample-size justification are reported in the registry record. The illustrations therefore should not be interpreted as a description of the trial's original design or as a post hoc claim about the probability that the trial detected an effect.
What is not available for an inferential comparison?
The posted primary results are medians and confidence intervals by group. The registry record does not report a hazard ratio, a log-rank test, an adjusted model, or another between-group analysis. The stated statistical meaning for the time-to-event outcome is that only sponsor-reported hazard ratios are used, but no such hazard ratio is included in these posted results. Consequently, the available numerical summaries support description of the group outcomes, not a reconstructed treatment-effect estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies overall survival as the primary outcome and lists progression-free survival, frequency and severity of adverse effects, patient-reported quality of life, and patient-reported peripheral neuropathy symptoms as secondary outcomes. Four secondary outcomes are listed. The record does not report how multiplicity across outcomes, time points, or treatment comparisons was handled. It also does not report a prespecified hierarchy or adjustment procedure. Without that information, the role of any secondary findings in confirmatory inference cannot be determined.
The posted results include the overall-survival medians and confidence intervals, but no analyses are reported for the secondary outcomes. Missing outcome results should not be interpreted as showing no effect or no difference. The registry record does not report reasons for absent secondary results, the amount of missing patient-reported information, or the methods used to handle missing values.
For overall survival, the record says participants alive at last follow-up were censored on the date of last contact. It does not describe other missingness, loss to follow-up, censoring counts, or sensitivity analyses. The stated primary population is all randomized participants. The analysis populations used for the secondary outcomes and safety summaries are not described in detail.
The registry record does not report interim analyses, stopping rules, a statistical analysis plan, or a protocol-based sample-size justification. The planning illustrations are described as calculations based on the observed effect and stated assumptions; they should not be confused with the trial's original design rationale. These absences limit assessment of how outcomes, missing data, multiplicity, and analysis populations were addressed.
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 (Paclitaxel Poliglumex) | 50 | 379 | 13.2% |
| Arm II (Paclitaxel) | 39 | 374 | 10.4% |
| Arm III (Observation) | 1 | 386 | 0.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I (Paclitaxel Poliglumex) | 235 of 387 |
| Arm II (Paclitaxel) | 242 of 384 |
| Arm III (Observation) | 230 of 386 |
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 (Paclitaxel Poliglumex) | 378 of 379 |
| Arm II (Paclitaxel) | 372 of 374 |
| Arm III (Observation) | 312 of 386 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) |
|---|---|---|---|---|
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | 4 of 379 | 6 of 374 | 0 of 386 |
| Thrombosis/Thrombus/Embolism | Vascular disorders | 4 of 379 | 2 of 374 | 0 of 386 |
| Neutrophils | Blood and lymphatic system disorders | 2 of 379 | 3 of 374 | 0 of 386 |
| Wound Complication, Non-Infectious | Skin and subcutaneous tissue disorders | 2 of 379 | 1 of 374 | 0 of 386 |
| Obstruction, Gi - Ileum | Gastrointestinal disorders | 0 of 379 | 3 of 374 | 0 of 386 |
| Ileus | Gastrointestinal disorders | 1 of 379 | 2 of 374 | 0 of 386 |
| Vomiting | Gastrointestinal disorders | 2 of 379 | 1 of 374 | 0 of 386 |
| Dehydration | Gastrointestinal disorders | 2 of 379 | 1 of 374 | 0 of 386 |
| Neuropathy-Motor | Nervous system disorders | 1 of 379 | 2 of 374 | 0 of 386 |
| Rhinitis | Immune system disorders | 2 of 379 | 0 of 374 | 0 of 386 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I (Paclitaxel Poliglumex) | Arm II (Paclitaxel) | Arm III (Observation) |
|---|---|---|---|---|
| Neuropathy-Sensory | Nervous system disorders | 318 of 379 | 294 of 374 | 175 of 386 |
| Fatigue | General disorders | 254 of 379 | 277 of 374 | 143 of 386 |
| Hemoglobin | Blood and lymphatic system disorders | 270 of 379 | 283 of 374 | 83 of 386 |
| Leukocytes | Blood and lymphatic system disorders | 229 of 379 | 231 of 374 | 44 of 386 |
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | 135 of 379 | 239 of 374 | 76 of 386 |
| Neutrophils | Blood and lymphatic system disorders | 190 of 379 | 213 of 374 | 28 of 386 |
| Constipation | Gastrointestinal disorders | 156 of 379 | 158 of 374 | 88 of 386 |
| Nausea | Gastrointestinal disorders | 145 of 379 | 137 of 374 | 63 of 386 |
| Pain: Abdominal Pain Nos | General disorders | 111 of 379 | 102 of 374 | 120 of 386 |
| Pain: Joint | General disorders | 106 of 379 | 133 of 374 | 81 of 386 |
Serious events with the highest arm-level rate: obstruction, gi - small bowel nos (1.6%), thrombosis/thrombus/embolism (1.1%), neutrophils (0.8%), obstruction, gi - ileum (0.8%), ileus (0.5%).
The registry reports serious adverse events among 379 participants at risk in the paclitaxel poliglumex group, 374 in the paclitaxel group, and 386 in the observation group. The corresponding counts affected by serious adverse events are 50, 39, and 1. These are group-level counts, not estimates of the causal effect of treatment. The registry does not provide a comparative statistical analysis of these figures.
For other adverse effects, the reported at-risk and affected counts are 379 and 378 for paclitaxel poliglumex, 374 and 372 for paclitaxel, and 386 and 312 for observation. The record labels these as other adverse effects, a category distinct from serious adverse events. The counts do not convey severity for each event or indicate how often an individual experienced repeated events.
The listed serious adverse-event terms include obstruction, GI - small bowel NOS at 1.6%, thrombosis/thrombus/embolism at 1.1%, neutrophils at 0.8%, obstruction, GI - ileum at 0.8%, ileus at 0.5%, and neuropathy-motor at 0.5%. The denominator and detailed coding basis for these percentages are not reported in the registry record. The listed terms should not be taken as a complete account of all serious events.
Deaths are listed as 235, 242, and 230 across the three groups. These counts are not accompanied by a safety comparison or attribution of cause in the posted results. Overall survival counts death from any cause, while adverse-event reporting has its own definitions and risk sets; the two types of figures should not be treated as interchangeable.
12. What the Result Does, and Does Not, Mean
The posted results describe median overall survival in three randomized groups after complete clinical response to primary platinum/taxane chemotherapy. The medians are 60.0 months for paclitaxel poliglumex, 56.8 months for paclitaxel, and 58.3 months for observation. Each is accompanied by a 95% confidence interval, conveying uncertainty in the group estimate. These summaries answer a descriptive question about the observed survival distributions in the registry's stated population.
They do not, on their own, establish that one strategy is superior, equivalent, or non-inferior to another. The registry does not report a hazard ratio or a formal between-group test for overall survival. No statistical significance conclusion can be recovered simply by comparing the medians or noting overlap between their confidence intervals. A valid inference about relative effects requires a defined comparison and its estimate and uncertainty, which are not reported in the posted results.
The trial's question is specific to maintenance strategies in participants who had achieved a complete clinical response to primary platinum/taxane chemotherapy. The results do not directly describe initial chemotherapy, people who did not achieve that response, or populations beyond the listed advanced ovarian, primary peritoneal, and fallopian tube cancers. They also do not answer questions about progression-free survival, quality of life, peripheral neuropathy symptoms, or the full comparative safety profile, because those results are not posted.
The safety figures give counts affected within reported risk sets and selected serious-event terms. They do not by themselves estimate comparative risk, account for differences in follow-up, or establish that an event was caused by a treatment. Likewise, deaths listed for each group should not be used to infer a survival comparison in place of the time-to-event analysis.
Overall, the registry supports a careful description of the group-specific survival estimates and selected safety counts. It does not supply the inferential detail needed to determine the statistical evidence for a difference between strategies. The absence of a posted comparison is not evidence that the strategies are the same; it is a limit on what can be concluded from this record.
13. Why This Trial Matters Statistically
This trial is statistically notable for asking a maintenance-treatment question against an observation group after response to primary chemotherapy. The randomized parallel design creates a framework for comparing treatment strategies in the enrolled population, while the no-masking design means the interventions were not masked. Overall survival is a time-to-event endpoint, so its interpretation depends on follow-up duration, censoring, and the way the survival distribution is estimated.
The registry provides group-specific medians and confidence intervals, which are useful descriptive summaries, but does not provide a hazard ratio, test, or other direct comparison for the primary outcome. This illustrates an important distinction: reporting an estimate for each group is not the same as reporting an estimate of the contrast between groups. The posted results can be read as estimates with uncertainty, but they do not give the inferential result needed to assess a treatment contrast.
The observation group also clarifies the clinical comparison: the study considered continued maintenance chemotherapy versus no further anticancer treatment until progression. This makes clear why the results should be interpreted in the post-response setting rather than generalized to all stages of treatment. The listed secondary outcomes indicate that the trial also considered progression, adverse effects, quality of life, and neuropathy symptoms, though their results are not included in the registry's posted analyses.
Finally, the record distinguishes observed results from planning illustrations based on the observed effect. That distinction matters because planning calculations are not observed power and do not substitute for a protocol's rationale or a reported treatment-effect analysis. Here, protocol-level sample-size justification, multiplicity handling, and inferential comparison details are not reported in the registry record. Those omissions define the boundary between what can be described and what can be concluded statistically.
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 main limitation of the posted results is that the primary outcome is reported by group without a direct inferential comparison. The registry includes medians and 95% confidence intervals but no hazard ratio, comparison interval, test statistic, or p-value for overall survival. As a result, the relative treatment effect and its statistical uncertainty cannot be assessed from these results alone.
The registry does not report the method used to estimate medians or confidence intervals, the detailed survival model, or checks of model assumptions. It states that participants alive at last follow-up were censored at last contact, but does not report censoring counts, reasons for incomplete follow-up, or sensitivity analyses. The follow-up schedule is described, but visit completion and completeness of outcome ascertainment are not reported.
Secondary outcomes are named but their numerical results and analyses are not posted. The multiplicity approach, analysis populations for secondary outcomes, handling of missing patient-reported data, interim analyses, and statistical analysis plan are not reported in the registry record. The overall study status is recorded as UNKNOWN, which also limits interpretation of the record's administrative status.
Safety results are presented as affected counts in reported risk sets, with selected serious-event terms and percentages. The record does not explain the denominator basis for those term percentages or provide a comparative safety model. The listed figures therefore do not establish treatment-attributable risk. Finally, sample-size illustrations are described as based on observed effects rather than as the trial's own design justification; the original sample-size rationale is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer — NCT00108745.
- Registry record last updated 2021-09-30; status last verified 2021-09.
- Results first posted 2021-04-01.
- 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
NCT00108745 is a randomized, open-label, parallel-group phase III trial sponsored by the GOG Foundation. It enrolled participants with advanced ovarian, primary peritoneal, or fallopian tube cancer who achieved a complete clinical response to primary platinum/taxane chemotherapy. The groups received paclitaxel poliglumex, paclitaxel, or observation.
Overall survival was defined as months from enrollment to death from any cause, with participants alive at last contact censored at that date. The registry reports medians of 60.0 months, 56.8 months, and 58.3 months, respectively, with group-specific 95% confidence intervals. A hazard ratio or formal primary-outcome comparison is not reported. Secondary outcomes are listed, but their analyses are not posted. The record lists a start date of 2005-03-21, a primary completion date of 2015-02-03, and status UNKNOWN.