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 Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer (NCT00063999), a randomized phase 3 study. The primary outcome is Number of Participants Alive at Time of Last Follow-up..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00063999 |
| Phase | Phase 3 |
| Condition | Recurrent Uterine Corpus Carcinoma, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1381 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GOG Foundation |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled patients with stage III-IV or recurrent endometrial cancer. The conditions listed include recurrent uterine corpus carcinoma and stage IIIA, IIIB, IIIC, IVA, and IVB uterine corpus cancer. The primary-outcome population is described as eligible and treated patients, with data from the second interim analysis. Further eligibility criteria, including any requirements that determined who could enter the trial, are not reported in the registry record.
Intervention
Arm I received doxorubicin hydrochloride, cisplatin, and paclitaxel, with filgrastim or pegfilgrastim support. Treatment was scheduled to repeat every 21 days for 7 courses in the absence of disease. The registry record describes the drugs, routes, and treatment days, but does not report adherence or the amount of treatment participants actually received.
Comparator
Arm II received paclitaxel and carboplatin. Treatment was scheduled to repeat every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. The registry record does not report how many participants completed the planned courses in either arm.
Primary question
The primary outcome is the number of participants alive at last follow-up. The stated measure is time alive in months from study entry to last contact or death, with follow-up described for a maximum of 10 years. The record does not give arm-specific primary-outcome counts, a between-arm estimate, a confidence interval, or a test result. It therefore does not establish a comparative estimate for this outcome.
3. Trial Design
This was a randomized, open-label, parallel-group phase III trial sponsored by GOG Foundation. The registry lists enrollment as 1381 and status as completed. It describes two chemotherapy regimens: doxorubicin hydrochloride, cisplatin, and paclitaxel with growth-factor support, versus paclitaxel and carboplatin. Both regimens were scheduled for 7 courses, with treatment repeating every 21 days subject to the conditions described for each arm.
The record gives a start date of 2003-08-25 and a primary completion date of 2013-06-29. These dates describe the trial record; they do not supply details about the timing of individual participants’ enrollment, follow-up, or treatment completion. The study is identified as randomized, but the method used to generate the allocation sequence, how allocation was concealed, and whether randomization was stratified are not reported in the registry record.
Masking is listed as none. Participants and study personnel therefore were not described as masked in the record. The record does not specify whether outcome assessors or analysts were masked. It also does not give arm-specific enrollment totals in the trial design information, or explain how participants who did not receive assigned treatment were handled in the primary analysis.
The primary outcome is described as the number of participants alive at last follow-up, measured from study entry to last contact or death. The outcome population is eligible and treated patients, and the data are identified as coming from the second interim analysis. The record gives a follow-up schedule but no primary-outcome comparison or statistical analysis. The reason for the reported interim analysis and any planned monitoring procedures 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 | Doxorubicin, Cisplatin, Paclitaxel | Paclitaxel, Carboplatin |
|---|---|---|
| STARTED | 692 | 689 |
| COMPLETED | 647 | 665 |
| NOT COMPLETED | 45 | 24 |
Reasons for not completing this period:
| Reason | Doxorubicin, Cisplatin, Paclitaxel | Paclitaxel, Carboplatin |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
| Ineligible | 44 | 24 |
Analysis population for the primary outcome, as defined in the registry: Eligible and treated patients. Data are reported from the second interim analysis.
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: Eligible and treated patients
| Characteristic | Unit | Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) | Arm II (Paclitaxel, Carboplatin) | Total |
|---|---|---|---|---|
| Participants analysed | 647 | 665 | 1312 | |
| Age, Customized: <40 years | Participants | 19 | 18 | 37 |
| Age, Customized: 40 -49 years | Participants | 67 | 70 | 137 |
| Age, Customized: 50-59 years | Participants | 192 | 219 | 411 |
| Age, Customized: 60-60 years | Participants | 256 | 244 | 500 |
| Age, Customized: >=70 years | Participants | 113 | 114 | 227 |
| Sex: Female, Male: Female | Participants | 647 | 665 | 1312 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Alive at Time of Last Follow-up., measured over Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the number of participants alive at last follow-up. The registry describes the underlying measure as time alive in months from study entry to last contact or death. Follow-up was assessed during treatment and, after treatment completion, every 3 months for 2 years, every 6 months for 3 years, and annually after that for a maximum of 10 years.
In general, survival outcomes are used to describe whether participants remain alive over follow-up and how long they are observed before death or last contact. Time-to-event methods can account for differing observation times and for participants whose outcome is not known at the end of observation. Those methods require an analysis definition and assumptions about censoring; the registry record does not report the method used for the primary outcome, or explain how last-contact observations were handled statistically.
The record identifies eligible and treated patients as the primary-outcome population and says the data come from the second interim analysis. It does not report the arm-specific counts alive, a time-to-event estimate, a comparison between arms, or uncertainty around such an estimate. The primary endpoint’s title refers to a count, but the description uses time alive. Without the posted comparison and analysis details, the endpoint definition alone cannot show the magnitude or precision of any difference between regimens.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant comparative question: how outcomes differ between two chemotherapy combinations among patients with stage III-IV or recurrent endometrial cancer. It describes a randomized phase III design and names a primary outcome, but it does not post the primary-outcome estimates or a statistical comparison. The central interpretive limitation is therefore the absence of an effect estimate and its uncertainty. The record cannot support a conclusion about the direction, size, or precision of a difference in survival between arms.
The primary outcome is listed as a count of participants alive at last follow-up, while its description defines time alive from study entry to last contact or death. These descriptions indicate that follow-up time and censoring may be relevant, but the registry record does not state the analysis method or report time-to-event estimates. A count at a particular follow-up point and a time-to-event analysis answer related but not identical questions. The exact endpoint analysis cannot be inferred from the description alone.
The adverse-event information gives arm-specific numbers at risk and numbers affected, as well as deaths. For serious adverse events, the record lists 217 among 647 at risk in Arm I and 156 among 665 at risk in Arm II. For the other adverse-event figures, it lists 631 among 647 at risk in Arm I and 657 among 665 at risk in Arm II. The death counts listed are 271 and 280, respectively. These are descriptive counts in the safety information, not a reported primary-outcome analysis. The record does not specify whether the death counts use the same population, follow-up definition, or analysis rules as the primary endpoint, so they should not be treated as a substitute for the missing primary comparison.
The record lists serious-event terms with percentages, including thrombosis/embolism at 5.1% and neutrophils/granulocytes at 3.9%. Such entries describe events recorded in the safety data; without further details about event definitions, observation time, and statistical comparisons, they do not quantify a comparative treatment effect. The registry does not report confidence intervals or hypothesis tests for these figures.
Overall, the record supports a description of trial design, outcome definitions, and selected safety counts. It does not provide enough outcome analysis to quantify comparative efficacy or precision. The absence of a reported estimate is not evidence that the regimens had equal outcomes, nor does it show that either regimen was superior.
9. Statistical Methods Explained
The methods information available in the registry record is limited. It identifies a randomized phase III parallel-group trial with no masking, names the primary outcome, and gives a follow-up description. It does not report the statistical model, test, analysis population rules, missing-data methods, or a primary-outcome estimate. The explanations below describe general statistical ideas and distinguish them from methods actually documented for this trial.
What does randomization contribute?
In general, randomization assigns participants to study arms by chance. When implemented successfully, it helps balance both measured and unmeasured prognostic factors across arms on average. This supports a fairer comparison than one based only on treatment received in routine care. Randomization does not guarantee identical groups, and the result still depends on how the study handles departures from assignment, incomplete follow-up, and outcome measurement. The registry record identifies the trial as randomized but does not report the sequence-generation method, allocation concealment, or stratification factors.
What does an open-label design mean?
The record lists masking as none. In general, an open-label study means participants and treating teams know which intervention is being given. Awareness of treatment can affect treatment delivery, reporting of subjective symptoms, and decisions that influence follow-up. Outcomes such as death are less dependent on subjective reporting than patient-reported quality of life, but their analysis can still be affected by differences in follow-up or missing outcome information. The record does not say whether outcome assessors or data analysts were masked, so no further masking procedure can be assumed.
How should a survival endpoint be analyzed?
In general, a time-to-event analysis uses both the event status and the time until an event or censoring. Censoring occurs when a participant’s event time is not observed during the available follow-up; last contact may be used to establish the last known status. Methods such as Kaplan-Meier estimation can describe survival over time, while regression models can compare groups while accounting for follow-up. These methods rely on assumptions, including assumptions about censoring and, for some models, the relative pattern of hazards over time.
The registry describes time alive from study entry to last contact or death and gives a follow-up schedule, but it does not report that Kaplan-Meier estimation, a regression model, or any other specific method was used. Nor does it provide a hazard ratio, survival probability, median survival, confidence interval, or primary-outcome test. None of those statistics can be reconstructed from the event counts in the safety information.
What does a confidence interval add?
In general, a confidence interval gives a range of values compatible with the observed data under a statistical procedure and its assumptions. It communicates precision: a narrower interval indicates more precise estimation than a wider interval, while the interval’s position describes which effect sizes remain compatible with the data. A confidence interval is not a guarantee that the true effect lies within its limits. The registry record does not report a confidence interval for the primary outcome, so its precision cannot be assessed from the posted outcome information.
What does a p-value answer?
In general, a p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the test assumptions were true. It does not measure the probability that the null hypothesis is true, nor does it describe the size or clinical importance of an effect. A p-value is most informative alongside an estimate and confidence interval. The registry record reports no primary-outcome p-value or test result.
Why can event counts be insufficient?
Counts alone do not incorporate the time each participant was observed. In survival settings, participants can have different follow-up durations, and a simple count may not capture when events occurred. A valid comparison needs an endpoint definition, analysis population, follow-up rules, and statistical method. The registry gives a description of follow-up but does not document how these elements were combined in an analysis.
What do the planning assumptions mean?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, sample-size planning asks how many participants or events would be needed to achieve a chosen probability of detecting an effect under stated assumptions. Such a calculation is a planning illustration, not observed evidence that a trial had a particular probability of success. The record does not report the trial’s own sample-size justification, and numeric planning results are not reported in the registry record.
For count outcomes, over-dispersion is a general concern when variability exceeds what a simple count model assumes. Ignoring it can make uncertainty appear too small. The record does not report a count-model analysis or dispersion estimate for this endpoint, so it is not possible to assess whether over-dispersion was considered. No analysis results are listed in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including the primary survival outcome, patient-reported neurotoxicity, patient-reported quality of life, survival by estrogen or progesterone receptor status, and graded neurotoxicity and infection. Considering multiple outcomes or subgroup comparisons can increase the chance of at least one apparently unusual result when many tests are conducted. In general, a statistical plan may address this through a hierarchy of outcomes, adjusted significance thresholds, or an explicit distinction between confirmatory and exploratory analyses.
Multiplicity procedures for this trial are not reported in the registry record. The record does not describe an outcome-testing hierarchy, adjustment method, or prespecified subgroup analysis plan. The registry lists a receptor-status outcome, but does not report its analysis or how that comparison relates to the primary outcome.
Missing-data methods are also not reported in the registry record. The endpoint description uses last contact or death and specifies ongoing follow-up, but it does not explain how participants lost to follow-up, withdrawn from treatment, or missing outcome information were handled. In general, incomplete follow-up can affect a survival analysis if the likelihood of being censored is related to prognosis. The assumptions and sensitivity analyses needed to assess that issue are not described.
The primary-outcome population is stated as eligible and treated patients. The record does not report whether the primary analysis included all randomized participants, only treated participants, or another defined group. It also does not explain how exclusions after randomization were handled. The number of analyses listed is 0, and no primary-outcome comparison is reported. Consequently, the registry record does not provide enough detail to assess multiplicity control, missing-data sensitivity, or the implications of the analysis population.
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 (Doxorubicin, Cisplatin, Paclitaxel) | 217 | 647 | 33.5% |
| Arm II (Paclitaxel, Carboplatin) | 156 | 665 | 23.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 271 of 647 |
| Arm II (Paclitaxel, Carboplatin) | 280 of 665 |
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 (Doxorubicin, Cisplatin, Paclitaxel) | 631 of 647 |
| Arm II (Paclitaxel, Carboplatin) | 657 of 665 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | Arm II (Paclitaxel, Carboplatin) |
|---|---|---|---|
| Thrombosis/Embolism | Cardiac disorders | 33 of 647 | 16 of 665 |
| Neutrophils/Granulocytes | Blood and lymphatic system disorders | 16 of 647 | 26 of 665 |
| Febrile Neutropenia-Fuo Infect Not Docum | Infections and infestations | 14 of 647 | 14 of 665 |
| Infection Documented W Grd 3/4 Neutropn. | Infections and infestations | 18 of 647 | 9 of 665 |
| Dehydration | Gastrointestinal disorders | 16 of 647 | 9 of 665 |
| Infection Without Neutropenia | Infections and infestations | 17 of 647 | 8 of 665 |
| Hemoglobin | Blood and lymphatic system disorders | 5 of 647 | 10 of 665 |
| Vomiting | Gastrointestinal disorders | 13 of 647 | 2 of 665 |
| Diarrhea (Without Colostomy) | Gastrointestinal disorders | 9 of 647 | 1 of 665 |
| Nausea | Gastrointestinal disorders | 7 of 647 | 3 of 665 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | Arm II (Paclitaxel, Carboplatin) |
|---|---|---|---|
| Neutrophils/Granulocytes | Blood and lymphatic system disorders | 402 of 647 | 590 of 665 |
| Leukocytes | Blood and lymphatic system disorders | 418 of 647 | 556 of 665 |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | 473 of 647 | 486 of 665 |
| Hemoglobin | Blood and lymphatic system disorders | 445 of 647 | 410 of 665 |
| Platelets | Blood and lymphatic system disorders | 244 of 647 | 172 of 665 |
| Hematologic-Other | Blood and lymphatic system disorders | 202 of 647 | 156 of 665 |
| Nausea | Gastrointestinal disorders | 218 of 647 | 122 of 665 |
| Neuropathy: sensory | Nervous system disorders | 163 of 647 | 128 of 665 |
| All other GI | Gastrointestinal disorders | 163 of 647 | 125 of 665 |
| Vomiting | Gastrointestinal disorders | 165 of 647 | 82 of 665 |
Serious events with the highest arm-level rate: thrombosis/embolism (5.1%), neutrophils/granulocytes (3.9%), infection documented w grd 3/4 neutropn. (2.8%), infection without neutropenia (2.6%), dehydration (2.5%).
The safety information lists serious adverse-event figures for Arm I and Arm II. It reports 217 affected among 647 at risk in Arm I, and 156 affected among 665 at risk in Arm II. The other adverse-event figures are 631 among 647 at risk in Arm I and 657 among 665 at risk in Arm II. The registry does not fully explain in this summary the definitions or collection rules for these two categories, so they should be read using the labels attached to the posted safety data rather than treated as interchangeable measures.
Deaths are listed as 271 in Arm I and 280 in Arm II. These counts belong to the safety information and are not accompanied by a comparative estimate, confidence interval, or test result. The primary outcome is separately described as alive at last follow-up; the registry does not establish that the safety death counts are the primary-outcome analysis counts.
The most frequently listed serious-event terms include thrombosis/embolism at 5.1%, neutrophils/granulocytes at 3.9%, infection documented with grade 3/4 neutropenia at 2.8%, infection without neutropenia at 2.6%, dehydration at 2.5%, and febrile neutropenia with infection not documented at 2.2%. These percentages are reported as event-term figures. The record does not provide additional context on event duration, recurrence, exposure time, or statistical uncertainty. They should therefore be interpreted as descriptive safety information, not as a complete comparison of risk between treatment groups.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized phase III comparison of two chemotherapy combinations in patients with stage III-IV or recurrent endometrial cancer. It describes the treatment schedules, the follow-up approach, the primary outcome, and selected safety counts. These details help define the clinical question and the kinds of outcomes the trial set out to assess.
What the record does not provide is a reported primary-outcome comparison. It gives no arm-specific survival estimate, effect estimate, confidence interval, or p-value. As a result, the magnitude and precision of any difference between the regimens cannot be evaluated from this record. The absence of such a result should not be interpreted as evidence of no difference or as evidence that one regimen is better.
The safety data give counts of participants affected and several serious-event percentages. They can describe what was recorded, but do not by themselves establish a comparative treatment effect. Differences in counts cannot be interpreted without information about the analysis population, observation time, event definitions, uncertainty, and any statistical adjustment. The registry record does not provide those details for a comparative safety analysis.
The record also cannot establish whether the primary analysis followed an intention-to-treat approach, how incomplete follow-up was handled, or whether the stated interim analysis was part of a prespecified monitoring plan. Those details matter for interpreting trial estimates, but are not reported in the registry record.
The appropriate reading is therefore bounded: this is a completed randomized trial with a stated survival outcome and posted safety information, but the registry record does not report an analyzed primary comparison. No conclusion about comparative efficacy, survival precision, or overall safety balance can be drawn from the information reported in the record alone.
13. Why This Trial Matters Statistically
This trial illustrates why a study design and an outcome definition are not enough to interpret a clinical comparison. Randomized allocation can support a comparative design, and a long follow-up schedule can be relevant to survival outcomes. But interpretation also requires the analyzed outcomes, arm-specific estimates, uncertainty, and clear analysis rules. Those primary comparative results are not reported in the registry record.
The endpoint description also shows the importance of distinguishing a count from a time-to-event measure. The title names the number alive at last follow-up, while the description refers to time alive from study entry to last contact or death. In general, counts at a single point do not carry the same information as analyses that account for the timing of events and differing follow-up. An explicit analysis method is needed to understand how the endpoint was evaluated.
The record’s safety information illustrates another statistical distinction: descriptive event counts are not the same as a comparative estimate. Counts and percentages help describe recorded events, but comparisons also depend on definitions, observation time, population rules, and uncertainty. Without those, the figures should not be turned into claims about relative risk.
Finally, the record identifies a second interim analysis and multiple secondary outcomes, but does not report the interim-analysis plan, multiplicity approach, or missing-data methods. These omissions limit assessment of how confirmatory the analyses were intended to be and how robust results would be to alternative assumptions. The trial matters statistically because it highlights how much interpretive work depends on transparent reporting beyond design labels and outcome names.
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 primary limitation for interpreting this trial from the registry record is that the primary-outcome analysis is not reported. The record does not give arm-specific counts alive at last follow-up, a survival estimate, a between-arm contrast, or uncertainty around a contrast. Without these, the primary comparative question remains unanswered in the posted record.
The endpoint description combines a count title with a time-to-event description. The registry does not report the precise estimand, such as the specific survival time point or contrast intended for interpretation, or the statistical method used. It also does not explain how censoring or loss to follow-up was handled. The stated eligible-and-treated population is not accompanied by full analysis-population rules.
Although the record says the trial was randomized and unmasked, it does not report sequence generation, allocation concealment, stratification, or masking of outcome assessment and analysis. It also does not report adherence, treatment completion, or participant flow by arm. These omissions constrain assessment of the conduct of the comparison.
Multiplicity, missing-data procedures, and the rationale for the second interim analysis are not reported in the registry record. The sample-size justification for the trial is also not reported. Safety figures are descriptive and lack a reported comparative analysis, event-time context, and confidence intervals. Together, these gaps mean the record is useful for describing the trial’s design and selected outcomes but is insufficient for a full appraisal of comparative effects or statistical robustness.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer — NCT00063999.
- Registry record last updated 2021-10-19; status last verified 2021-09.
- Results first posted 2018-04-23.
- 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
NCT00063999 is a completed randomized phase III parallel-group trial sponsored by GOG Foundation. It enrolled patients with stage III-IV or recurrent endometrial cancer and compared doxorubicin hydrochloride, cisplatin, and paclitaxel with growth-factor support against paclitaxel and carboplatin. The registry lists enrollment as 1381 and gives a start date of 2003-08-25 and a primary completion date of 2013-06-29.
The primary outcome is the number alive at last follow-up, described in terms of time alive from study entry to last contact or death. Follow-up was scheduled for a maximum of 10 years. The outcome population is eligible and treated patients, with data identified as coming from the second interim analysis. The registry record does not report a primary-outcome comparison or analysis estimate.
Safety information includes serious and other adverse-event counts, deaths, and selected serious-event terms with percentages. The record does not provide a comparative safety analysis or report details of the statistical plan, missing-data methods, or multiplicity approach.