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 Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer (NCT01041027), a na phase 2 study. The primary outcome is Progression-free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01041027 |
| Phase | Phase 2 |
| Condition | Endometrial Adenocarcinoma, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Albert Einstein College of Medicine |
| Results posted | Yes |
2. Clinical Question
The study concerned a combined chemotherapy and radiation approach for patients with high-risk endometrial cancer after standard surgical staging. Its stated primary endpoint was progression-free survival (PFS), defined in the record by the time from randomization until documented tumor recurrence or death from any cause, with assessment planned up to 5 years. The registry record does not contain PFS results, and it states that PFS data were not collected and analyzed.
Population
Patients with high-risk endometrial cancer after standard surgical staging. The listed conditions include endometrial adenocarcinoma and uterine corpus cancer stages IA, IB, II, IIIA, IIIB, IIIC, IVA, and IVB. Further eligibility details are not reported in the registry record.
Intervention
The single treatment group received paclitaxel, carboplatin, and radiation therapy. The record describes chemotherapy courses in weeks 1-9 and 13-21, with radiation therapy during weeks 8-13 or 8-15. Further regimen details are not fully reported in the registry record.
Comparator
There was no separate comparison group: the design is listed as single group, with allocation recorded as NA. The study therefore does not provide a randomized, like-for-like estimate contrasting this regimen with another treatment or with no treatment.
Primary question
The intended primary question concerned PFS following the treatment approach. The record gives a planned time-to-event definition and describes Kaplan-Meier estimation, but says PFS data were not collected and analyzed. An estimate of PFS or a treatment contrast is therefore not available in the registry record.
The endpoint wording refers to time from randomization, although the study is listed as single group with allocation NA. How that wording was intended to apply to this study is not reported in the registry record.
3. Trial Design
This is a phase II, single-group trial sponsored by Albert Einstein College of Medicine. Allocation is listed as NA and masking as none. Enrollment is 31. With no separate control group, the design describes experience within the treatment group rather than a randomized comparison between treatments. The registry status is terminated. The listed start date is 2009-01-16, and the primary completion date is 2019-10-01. The reason for termination is not reported in the registry record.
The treatment group is described as receiving paclitaxel, carboplatin, and radiation therapy. The chemotherapy description specifies intravenous paclitaxel over 3 hours and intravenous carboplatin over 30 minutes on day 1, repeated every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. Radiation therapy is described for weeks 8-13 or 8-15. The available description is incomplete after its reference to treatment for stage I disease, so further details about radiation delivery or schedules are not reported in the registry record. Internal and external beam radiation are listed as interventions.
The registry lists nine outcome measures. PFS is the primary outcome, and listed secondary outcomes include expression levels of IGF-1, IGF-2, IGFBP-1, IGFBP-3, insulin receptor, IGF-1 receptor, estrogen receptor, and progesterone receptor. The record does not report analyzed results for these outcomes. It also does not report a protocol-level sample-size justification, the reason for termination, or further details about the eligibility criteria. These omissions limit how much can be inferred about the study's intended conduct or its clinical findings.
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.
Before assignment: 40 participants were recruited. Of the 40 participants, 1 participant was not consented and 8 participants screen failed. 31 participants were enrolled and randomized into the study.
Overall Study
| Stage | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) |
|---|---|
| STARTED | 31 |
| COMPLETED | 23 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) |
|---|---|
| Withdrawal by Subject | 2 |
| Protocol Violation | 1 |
| Delayed Radiation Therapy | 1 |
| Adverse Event | 4 |
Analysis population for the primary outcome, as defined in the registry: PFS data was not collected and analyzed.
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 | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) |
|---|---|---|
| Participants analysed | 31 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 23 |
| Age, Categorical: >=65 years | Participants | 8 |
| Sex: Female, Male: Female | Participants | 31 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 19 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 8 |
| Race (NIH/OMB): White | Participants | 12 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 |
| Region of Enrollment: United States | participants | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS), measured over From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
PFS is a time-to-event endpoint. In this record, it is defined as the time from randomization until documented tumor recurrence or death from any cause, with assessment planned up to 5 years. Combining recurrence and death into one endpoint can capture more than one way that a participant may experience disease progression or a serious health outcome. It also means that a PFS event is not limited to tumor recurrence.
The registry describes Kaplan-Meier methods for estimating the PFS distribution, with the median time to progression and 95% confidence intervals to be estimated from the curves. In general, a time-to-event analysis uses the timing of events and can account for participants whose event time is not observed during follow-up through censoring, under assumptions about how follow-up ends. The registry record does not state how censoring was handled in practice.
The record explicitly states that PFS data were not collected and analyzed. It therefore contains no PFS estimate, median, confidence interval, or analysis of the endpoint. Although the planned timeframe is stated as up to 5 years, this does not establish that participants were followed for that duration. The record's reference to randomization also sits alongside a single-group design with allocation NA; how the endpoint timing was operationalized is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is the absence of an analyzed PFS result. PFS was designated as the primary endpoint, and a method for estimating it was described, but the registry record states that PFS data were not collected and analyzed. There is consequently no posted estimate of the time-to-event distribution, no median PFS, and no 95% confidence interval to interpret. The record does not establish whether or when tumor recurrence occurred among participants for purposes of this endpoint.
The design also has no comparator group. Enrollment of 31 describes the planned or recorded enrollment, not the number of participants with complete endpoint follow-up or an analyzed PFS population. Because no control group is listed, the study cannot furnish a randomized between-group contrast. The intervention description identifies the treatment approach, but the registry record does not report an analyzed estimate that could characterize outcomes within the group.
For safety, the registry lists 31 participants at risk for serious adverse events, with 2 affected, and 31 at risk for other adverse events, with 5 affected. It also lists 3 deaths. The record does not establish whether deaths were related to treatment, nor does it give enough information to infer their timing or circumstances. Serious adverse-event terms include anemia, neutropenia, thrombocytopenia, vaginal hemorrhage, and catheter related infection, each with a listed percentage. These entries are descriptive registry data, not comparative estimates of safety.
Secondary outcomes concern expression levels of several biomarkers and hormone receptors. The record lists these outcomes but does not provide analyzed findings. Without numerical results, estimates of uncertainty, or descriptions of the analysis populations, no direction or precision of biomarker changes can be interpreted from the record.
Planning illustrations based on an observed effect, where available in the accompanying material, should not be read as observed power or as a substitute for trial results. Such illustrations do not supply the missing PFS analysis, and they do not change the single-group design. Overall, the registry record documents a trial design and some safety counts, but it does not provide the primary endpoint findings needed to assess PFS statistically.
9. Statistical Methods Explained
What would a Kaplan-Meier estimate describe?
Kaplan-Meier estimation is a general method for describing time until an event. For this study, the planned event was documented tumor recurrence or death from any cause. The method uses the observed event times together with each participant's follow-up time to estimate the probability of remaining free of the defined event over time. It can incorporate censored observations, where the event time is not known because follow-up ends before an event is observed. Censoring is not the same as an event; it indicates that the participant's event-free time is known only up to a point.
Those are general properties of the method, not a description of a completed analysis in this trial. The registry record says PFS data were not collected and analyzed. It does not report participant-level follow-up, event counts for PFS, censoring details, or a Kaplan-Meier curve. Therefore, there is no study-specific survival distribution to interpret.
What would the median and confidence interval mean?
In general, the median of a time-to-event distribution is the time by which an estimated half of the group has experienced the event, if the estimate can be determined from the observed follow-up. It is a summary of the distribution, not a guarantee about an individual participant's course. A confidence interval expresses uncertainty around an estimate under the statistical method and its assumptions. A wider interval generally indicates less precision, while a narrower interval indicates greater precision. Neither a median nor an interval is reported for PFS in this record, so no value or degree of precision can be assessed.
The endpoint description says median time to progression and 95% confidence intervals would be estimated from Kaplan-Meier curves. The endpoint itself includes death from any cause as well as documented recurrence, while the planned summary is worded as median time to progression. The record does not explain how those terms were reconciled in the analysis. It also refers to time from randomization despite listing a single-group design and allocation NA. The intended time origin and analytic implementation are not reported in the registry record.
Why does the study design matter?
A single-group study can describe outcomes among participants receiving a treatment regimen if the relevant outcomes are collected and analyzed. Without a concurrent comparator, however, it cannot isolate the effect of the regimen from other explanations for observed outcomes. General examples include differences in participant characteristics, the course of disease, or care outside the study; these are methodological possibilities, not findings about this trial. Random assignment can help balance measured and unmeasured factors between groups, but this record does not describe a randomized comparison.
That limitation is separate from the missing PFS analysis. Even a complete single-group PFS estimate would describe the group's observed time-to-event experience, not provide a randomized estimate of the difference attributable to treatment. In this record, the endpoint was not analyzed, so even that descriptive estimate is unavailable.
How should planning illustrations be read?
General sample-size calculations ask how many participants or events might be needed to detect a specified effect under stated assumptions. The accompanying assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. These are planning illustrations based on the observed effect, not the trial's own design. They do not describe actual enrollment, an observed treatment comparison, or observed power. The trial itself is listed as single group, so the equal-allocation assumption for a two-arm illustration is not a description of its design.
In general, power is a property of a design under specified assumptions, not a probability that a particular result is true. A planning calculation does not show that the study achieved a result, and it cannot recover an endpoint that was not analyzed. No protocol sample-size justification is reported in the registry record. Further numerical assumptions or trial-specific sample-size rationale should not be inferred from the planning approach alone.
For count outcomes, general statistical methods may need to account for over-dispersion, when variability exceeds what a simpler model assumes. That concern is not a reported feature or analysis of this trial. The registry record does not describe a count-outcome analysis plan. Likewise, it does not report methods for biomarker analyses, adjustment for baseline factors, handling of missing measurements, or sensitivity analyses. These methods cannot be attributed to the study based on the available record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists PFS as the primary outcome and eight secondary outcomes concerning expression levels of IGF-1, IGF-2, IGFBP-1, IGFBP-3, insulin receptor, IGF-1 receptor, estrogen receptor, and progesterone receptor. It reports nine outcome measures in total. Testing or estimating multiple outcomes can raise multiplicity concerns: when many questions are examined, the chance of at least one apparently notable result may increase. General approaches include defining a primary question in advance, controlling error across a family of tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy or a hierarchy for interpreting the secondary outcomes.
The record states that PFS data were not collected and analyzed. It does not provide analyzed results for the listed secondary outcomes either. Whether biomarker measurements were collected, and whether any analyses were undertaken outside the registry record, is not reported in the registry record. No conclusion about the presence or absence of biomarker changes can be drawn from the outcome list alone.
Missing-data procedures and analysis populations are not reported in the registry record. There is no stated intention-to-treat or per-protocol population, no account of participants with missing measurements, and no description of imputation or sensitivity analyses. Enrollment is 31, but that number alone does not show how many participants would have been eligible for each outcome analysis or had complete follow-up. The registry's PFS timeframe is up to 5 years; actual follow-up duration is not reported. These gaps prevent assessment of how missing observations, outcome availability, or participant inclusion could affect an estimate.
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 |
|---|---|---|---|
| Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | 2 | 31 | 6.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | 3 of 31 |
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 |
|---|---|
| Treatment (Paclitaxel, Carboplatin, Radiation Therapy) | 5 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 2 of 31 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 31 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 31 |
| Vaginal Hemorrhage | Reproductive system and breast disorders | 1 of 31 |
| Catheter related infection | Infections and infestations | 1 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Paclitaxel, Carboplatin, Radiation Therapy) |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 4 of 31 |
| Thrombocytopenia | Blood and lymphatic system disorders | 3 of 31 |
| Constipation | Gastrointestinal disorders | 3 of 31 |
| Nausea | Gastrointestinal disorders | 3 of 31 |
| Neuropathy (peripheral) | Nervous system disorders | 3 of 31 |
| Alopecia | Skin and subcutaneous tissue disorders | 2 of 31 |
| Diarrhea | Gastrointestinal disorders | 2 of 31 |
| Fatigue | General disorders | 2 of 31 |
| Paresthesia | Nervous system disorders | 2 of 31 |
| Hypomagnesemia | Metabolism and nutrition disorders | 1 of 31 |
Serious events with the highest arm-level rate: anemia (6.5%), neutropenia (6.5%), thrombocytopenia (3.2%), vaginal hemorrhage (3.2%), catheter related infection (3.2%).
The registry lists 31 participants at risk for serious adverse events and 2 affected. For other adverse events, it lists 31 at risk and 5 affected. These are separate reported categories. The record does not explain whether participants could appear in both categories, so the affected counts should not be combined. It also lists 3 deaths, without reporting in this summary whether they were attributed to treatment or providing their timing or circumstances.
The top serious adverse-event terms are anemia and neutropenia, each listed at 6.5%; thrombocytopenia, vaginal hemorrhage, and catheter related infection are each listed at 3.2%. These figures are registry entries for specific terms. The record does not provide the event-level detail, follow-up context, or a comparison group needed to interpret them as comparative risks.
Safety counts are descriptive. They do not by themselves establish whether an event was caused by treatment, how long it lasted, whether it resolved, or how severe it was beyond the serious-event classification. Nor can these counts be directly compared with another treatment group in this single-group design. The listed deaths should be read separately from the adverse-event term percentages; the registry record does not report a causal relationship between the deaths and the treatment.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II, single-group study of paclitaxel, carboplatin, and radiation therapy was registered for high-risk endometrial cancer after standard surgical staging. It identifies PFS as the primary endpoint and describes a planned Kaplan-Meier approach. It also documents enrollment of 31, a terminated status, a set of secondary biomarker outcomes, and adverse-event counts.
It does not establish a PFS result. The record explicitly says that PFS data were not collected and analyzed, so there is no estimate of event-free time, median, confidence interval, or description of the PFS experience to interpret. The listed secondary outcomes have no analyzed findings in the record. The planned endpoint timeframe does not show that participants were followed for that duration.
The record also does not establish a treatment effect. There is no separate control group or randomized comparison, and the reported safety counts are not comparative estimates. The listed deaths cannot be assigned to treatment on the basis of this record. Nor does the record explain why the study was terminated or whether the stated outcomes were collected for any participants.
These distinctions matter because a study's planned question, its design, and its reported findings are different kinds of information. A protocol description can show what investigators intended to measure; it is not evidence that the measure was analyzed. An enrollment count is not an endpoint estimate, and a list of adverse-event terms is not a causal assessment. The most defensible reading is therefore limited: the registry documents the study's design and some safety reporting, while the primary PFS result is unavailable in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a defined endpoint and an analyzed endpoint. PFS is described with a time-to-event definition and a planned estimation method, yet the registry record states that the data were not collected and analyzed. Without those data, readers cannot evaluate the event-time distribution, its uncertainty, or the planned summary. Clear reporting of outcome availability is therefore statistically consequential, not merely an administrative detail.
The single-group design is also central to interpretation. It can be used to describe outcomes in a treated group when outcomes are observed, but it does not provide a concurrent randomized contrast. Here, the limitation is compounded by the absence of the primary endpoint analysis. Neither the treatment description nor the planning illustrations can fill that evidence gap.
The record also demonstrates why safety entries require careful reading. Counts of participants affected and percentages for listed event terms provide descriptive information, but without comparative data and attribution details they do not estimate a treatment-related difference. The 3 deaths are reported, but their relationship to treatment is not reported in the registry record.
For biostatisticians and clinical researchers, the study highlights the value of transparent reporting of analysis populations, follow-up, missing outcomes, multiplicity plans, and reasons for early termination. Those details help readers distinguish a planned statistical analysis from one that was actually completed. In this case, several of those details are not reported, and the primary endpoint is explicitly unavailable. The appropriate statistical conclusion is about the limits of the record, not about the clinical performance of the regimen.
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 consequential limitation is that the primary PFS data were not collected and analyzed. The registry therefore has no PFS estimate or uncertainty interval, despite describing a planned Kaplan-Meier analysis. Actual follow-up, event counts, censoring, and whether participants contributed any PFS observations are not reported in the registry record.
The trial is listed as single group, with allocation NA and masking none. It has no separate control arm for a like-for-like comparison. The endpoint definition refers to time from randomization, which does not align clearly with the listed single-group design; the intended time origin is not reported. The reason for the terminated status is also not reported.
The enrollment is 31, but the record does not state the number included in any analysis population or the number with measurements for each outcome. Methods for missing data, multiplicity, secondary biomarker analyses, and covariate adjustment are not reported. The record lists eight secondary biomarker outcomes but provides no analyzed findings for them.
The treatment description includes chemotherapy scheduling and broad radiation timing, but is incomplete in the available record. Detailed eligibility criteria, the protocol's sample-size justification, and further treatment-delivery details are not reported. Safety reporting includes participant counts and listed serious adverse-event terms, but does not provide attribution or a comparison group. These gaps limit assessment of both the planned methods and the observed clinical experience.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer — NCT01041027.
- Registry record last updated 2023-10-26; status last verified 2023-10.
- Results first posted 2023-10-26.
- 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
NCT01041027 is a phase II, single-group study sponsored by Albert Einstein College of Medicine. It evaluated paclitaxel, carboplatin, and radiation therapy for high-risk endometrial cancer after standard surgical staging. Enrollment is 31; allocation is NA, masking is none, and the registry status is terminated. The listed start date is 2009-01-16, and primary completion is dated 2019-10-01.
PFS was the primary endpoint, with a planned Kaplan-Meier analysis and a stated assessment timeframe up to 5 years. The registry record says PFS data were not collected and analyzed. Eight secondary outcomes concern biomarker or receptor expression; analyzed results are not reported. Safety entries list 2 participants affected by serious adverse events, 5 affected by other adverse events, and 3 deaths. The record does not report the reason for termination or whether deaths were related to treatment.