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 A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus (NCT00584909), a na phase 2 study. The primary outcome is Disease-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00584909 |
| Phase | Phase 2 |
| Condition | Uterine Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Alabama at Birmingham |
| Results posted | Yes |
2. Clinical Question
Population
Patients with intermediate-risk adenocarcinoma of the endometrium were the intended population, according to the official title. The condition is listed as uterine cancer. The registry record does not report further eligibility details or a separate description of the population included in the primary-outcome analysis.
Intervention
The intervention was a paclitaxel and carboplatin combination. The registry record describes the study as open label, with no masking. It does not report dose, schedule, treatment duration, or rules for changing or stopping treatment.
Comparator
No comparator group is reported. The study is listed as single group, and allocation is listed as not applicable. The registry record therefore does not describe a randomized comparison or a like-for-like control group.
Primary question
The stated primary outcome was disease-free survival, measured in months and summarized by its median. Its description is the number of months of survival with no evidence of disease. The registry record does not report the median, its range, or a treatment-effect estimate for this outcome.
3. Trial Design
This was a Phase II study of a paclitaxel and carboplatin combination in patients with intermediate-risk adenocarcinoma of the endometrium. The registry lists uterine cancer as the condition and University of Alabama at Birmingham as the sponsor. The study started in 2006-03, had a primary completion date of 2010-09, and is listed as terminated. The registry enrollment field reports 13; it does not establish from the information recorded whether all enrolled participants received treatment or contributed to each outcome analysis.
The design is listed as single group, with allocation not applicable and masking none. The arm is described as open label, and no control arm is reported. Consequently, the design does not support a randomized, within-trial comparison of the combination against another treatment or against no treatment. Outcomes can be described for the group, but changes over time or observed outcomes cannot by themselves separate treatment effects from other explanations.
The primary outcome is disease-free survival, with a stated timeframe of 4 years and a median follow-up time of 45.3 months. The registry also lists toxicity as a secondary outcome. It reports two outcome measures, but detailed outcome results and analysis results are not reported in the registry record. The registry reports zero analyses. It does not report the protocol, eligibility criteria beyond the population named in the title, treatment schedule, or statistical analysis plan.
The record's termination status is an administrative study status, not an explanation of why the study ended. The reason for termination is not reported in the registry record. Nor does the record explain whether termination affected recruitment, follow-up, or the planned analyses. These omissions limit interpretation of how closely the study proceeded to its intended completion.
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 | Paclitaxel + Carboplatin |
|---|---|
| STARTED | 13 |
| COMPLETED | 9 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Paclitaxel + Carboplatin |
|---|---|
| Adverse Event | 4 |
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 | Paclitaxel + Carboplatin |
|---|---|---|
| Participants analysed | 13 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 5 |
| Age, Continuous | years | 63 (SD 6) |
| Sex: Female, Male: Female | Participants | 13 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Disease-free Survival, measured over 4 years - Median follow up time of 45.3 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Disease-free survival was the primary endpoint. The registry describes it as the number of months of survival with no evidence of disease and specifies the median as the summary measure, with months as the unit. It gives a timeframe of 4 years and reports a median follow-up time of 45.3 months. No observed median or full range is reported in the registry record.
In general, a time-to-event endpoint records the elapsed time until a defined event, while accounting for participants whose event has not been observed by the end of follow-up. For disease-free survival, the exact event definition matters: it determines which clinical events count and how follow-up is handled. The registry's brief description refers to survival with no evidence of disease, but the detailed event criteria and censoring rules are not reported in the registry record.
In general, the median is the time by which half of the analyzed group has experienced the defined event, subject to the analysis method and follow-up available. It can be a useful summary when follow-up durations differ, but it does not convey the full pattern of events or precision on its own. The registry does not report a confidence interval, a range of observed event times, or a survival curve for this endpoint. The stated follow-up information describes the observation period; it is not itself an outcome estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a single-group Phase II study of paclitaxel and carboplatin and names disease-free survival as its primary outcome. It also reports enrollment of 13 and a median follow-up time of 45.3 months. These are design and follow-up details, not evidence of the magnitude or precision of an outcome. No disease-free survival median or other primary-outcome estimate is reported in the registry record.
The record does not report an effect estimate, confidence interval, or hypothesis-test result for the primary endpoint. It also reports zero analyses. Therefore, the posted registry information does not permit an assessment of how the observed disease-free survival compared with a benchmark, another treatment, or an expected outcome. A treatment comparison is especially unavailable because no comparator group is reported and the design is single group.
In general, a confidence interval expresses the range of effect estimates compatible with the data under a specified statistical procedure. Its width reflects precision, and it should be considered alongside the point estimate and study design. No confidence interval for disease-free survival is reported in the registry record, so precision cannot be evaluated from this record. The observed median and full range are also absent, preventing a direct description of the group’s observed time-to-event distribution.
The safety information is similarly limited. For the paclitaxel plus carboplatin group, the record lists 9 participants at risk for serious adverse events and 0 affected. It lists 9 at risk for other adverse events and 9 affected. Those counts describe the entries in the registry; they do not establish that all forms of harm were recorded or explain the severity, type, duration, or timing of the other events. No serious adverse event terms are listed among the top serious terms.
Enrollment of 13 and the safety denominators of 9 should not be assumed to refer to identical analysis populations. The registry does not explain the difference. It also does not report the number analyzed for disease-free survival, missing outcome data, or reasons for exclusion. Overall, the posted information documents the study design and selected safety counts but does not provide enough outcome analysis to quantify disease-free survival or its uncertainty.
9. Statistical Methods Explained
The registry record describes a time-to-event primary outcome summarized by a median. It does not report the outcome estimate or any analysis. The statistical concepts below are general explanations of how such outcomes are commonly interpreted; they are not claims about methods used in this study. The actual analysis plan is not reported in the registry record.
What does a time-to-event analysis describe?
In general, time-to-event methods summarize how long it takes for a specified event to occur. They can use information from participants whose event has not been observed by the end of follow-up, rather than treating their observed time as if it were the event time. Such participants are commonly described as censored, but the registry does not report whether or how censoring was handled in this study. A clear event definition and rules for follow-up are essential because they determine what each recorded time means.
The registry names disease-free survival and describes it as survival with no evidence of disease. It does not give detailed criteria for recurrence, death, or any other event that might contribute to the endpoint. It also does not specify the time origin, follow-up schedule, or censoring rules. Those details are not reported in the registry record, so the endpoint cannot be reconstructed in full from the available description.
What does a median mean?
In general, a median time-to-event estimate identifies the time by which half of the group is estimated to have experienced the event. Unlike an arithmetic average, it is based on the distribution of event times and can accommodate censoring when estimated using an appropriate method. The specific method used to estimate the median in this study is not reported in the registry record.
A median is only one summary of a time-to-event distribution. It does not show whether events were concentrated early or late, how the pattern changed over follow-up, or how uncertain the estimate is. A range can show the minimum and maximum observed values, but it does not convey the same information as a confidence interval. Although the primary outcome lists full range as its dispersion, no median or range is reported in the registry record. No confidence interval is reported either.
Why is follow-up information not an outcome estimate?
The outcome timeframe is recorded as 4 years, with median follow-up of 45.3 months. In general, follow-up describes how long participants were observed; it does not indicate how many experienced an event or when events occurred. A median follow-up duration cannot substitute for the median disease-free survival time. The registry does not report the follow-up estimation method, individual observation times, or event counts for disease-free survival.
What can a single-group design estimate?
In general, a single-group study can describe outcomes observed among participants in that group. Without a comparator, it cannot make a randomized within-study contrast between treatment strategies. Differences between observed outcomes and an external expectation may be affected by differences in patient characteristics, care, outcome definitions, or follow-up. The registry does not report a prespecified external benchmark or comparative analysis for this study.
Hazard ratios are relative measures sometimes used in time-to-event analyses, but no sponsor-reported hazard ratio is reported in the registry record. No unadjusted or adjusted comparison is described. A hazard ratio, if reported in another setting, would require interpretation alongside its confidence interval, endpoint definition, and analysis population; it would not by itself provide the absolute time-to-event experience of the group.
What does statistical precision require?
In general, an estimate is more informative when accompanied by a measure of uncertainty, such as a confidence interval. A confidence interval describes uncertainty under the model and assumptions used; it does not repair limitations in design, follow-up, or outcome reporting. The registry does not report a confidence interval for the primary outcome or an analysis model, so precision cannot be assessed from the posted results.
Sample-size planning is distinct from analysis of observed data. A planning illustration based on an observed effect is not an observed-power calculation and does not establish that a study was designed prospectively to detect that effect. The registry's own sample-size justification and statistical plan are not reported in the registry record. No reported analysis or effect estimate is available to interpret as the study's finding.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model ignores that extra variability, standard errors can be too small and confidence intervals too narrow. This concept is relevant to some count-data analyses, but the primary outcome is listed as time-to-event, and the registry does not report a model that can be assessed for over-dispersion. It would therefore be inappropriate to claim that over-dispersion was present or that a particular adjustment was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists disease-free survival as the primary outcome and toxicity as a secondary outcome. It also reports two outcome measures, but does not provide their detailed results or identify the second measure in the record. The number and definition of all planned analyses are not reported in the registry record; the analysis count is zero.
In general, multiplicity arises when several outcomes, time points, subgroups, or statistical tests are considered. Testing many hypotheses can increase the chance of at least one apparently noteworthy result unless the analysis plan addresses that issue. A prespecified hierarchy or adjustment may help control that risk, but no multiplicity strategy is reported in the registry record. It is not possible to determine whether the investigators planned multiple comparisons or how any such comparisons would have been handled.
Missing-data handling is not reported in the registry record. The record does not state how many participants contributed to the disease-free survival analysis, whether any outcome observations were missing, how incomplete follow-up was treated, or why participants might not have been included. The registry enrollment of 13 does not by itself establish the analysis population.
In general, the analysis population is the set of participants whose data are used for a particular estimate. Different outcomes can have different analysis populations, especially when follow-up or measurement availability differs. The registry does not identify an intention-to-treat, per-protocol, or other analysis population for disease-free survival or toxicity. These omissions prevent assessment of whether exclusions or missing observations could have influenced the posted estimates; no such estimates are reported in the registry record.
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 |
|---|---|---|---|
| Paclitaxel + Carboplatin | 0 | 9 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Paclitaxel + Carboplatin | 9 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel + Carboplatin |
|---|---|---|
| Neutropenia | Immune system disorders | 6 of 9 |
| Neuropathy | Nervous system disorders | 2 of 9 |
| Thrombocytopenia | Blood and lymphatic system disorders | 2 of 9 |
| Gastrointestinal | Gastrointestinal disorders | 1 of 9 |
| Urinary tract infection | Renal and urinary disorders | 1 of 9 |
| Anemia | Blood and lymphatic system disorders | 1 of 9 |
The registry lists one paclitaxel plus carboplatin group. For serious adverse events, it reports 9 participants at risk and 0 affected. For other adverse events, it reports 9 at risk and 9 affected. These are the recorded counts for the group; the record does not give event-level detail for the other adverse events.
The at-risk counts describe the denominator recorded for each category. They are not necessarily the same as the registry enrollment of 13, and the reason for the difference is not reported in the registry record. The record does not explain whether the categories use the same follow-up period, how events were collected, or whether participants could contribute to more than one event category.
In general, a zero count for reported serious adverse events means that none were recorded in that category for the stated at-risk group. It does not prove that a treatment has no serious risks, particularly when the group is small or the registry record does not describe ascertainment and follow-up in detail. Likewise, the count for other adverse events does not by itself indicate their severity or clinical importance. The registry lists no top serious adverse-event terms, and it does not report event timing, duration, management, or attribution. These figures should therefore be read as limited descriptive reporting, not as a complete safety profile or a comparison of risk between treatments.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a Phase II, single-group study of paclitaxel and carboplatin in patients with intermediate-risk adenocarcinoma of the endometrium. It identifies disease-free survival as the primary outcome and toxicity as a secondary outcome. It reports enrollment of 13, a median follow-up time of 45.3 months, and selected adverse-event counts. These details describe the study and its reporting; they do not provide a numerical estimate of disease-free survival.
The primary outcome's median, full range, confidence interval, and event count are not reported in the registry record. No hazard ratio or other effect estimate is reported. The record also reports zero analyses. As a result, the posted information cannot quantify the observed disease-free survival distribution or its precision. Nor can it establish how the study's outcomes compare with a control group, because no comparator group is reported.
In general, an observed outcome in a single group is descriptive. It cannot isolate the contribution of an intervention from the influence of participant characteristics, other care, or the course of the underlying condition. This limitation does not invalidate the descriptive information; it defines what can be inferred from the design. The registry does not report an external comparison or a prespecified benchmark that would support a comparative interpretation.
The safety counts are also descriptive and incomplete as a basis for broad conclusions. The record reports 0 affected among 9 at risk for serious adverse events and 9 affected among 9 at risk for other adverse events. It does not provide detailed event terms for the latter category, explain the denominators, or describe ascertainment. These counts cannot establish the overall frequency or comparative risk of harms.
The termination status is recorded, but the reason and consequences are not reported in the registry record. The record also does not state the analysis population, handling of missing follow-up, or statistical plan. Accordingly, interpretation should remain limited to the design, follow-up information, and adverse-event counts actually recorded. No conclusion about treatment effectiveness or lack of effectiveness follows from the absence of a posted endpoint estimate.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record identifies a clinically relevant time-to-event endpoint while reporting no endpoint estimate or analysis. That contrast illustrates why a named outcome and a follow-up duration are not enough to interpret a study's findings. Readers also need the observed estimate, its uncertainty, the event definition, and information about who contributed data.
The single-group design is central to the interpretation. It can provide a description of outcomes among the treated group, but it does not supply a randomized comparator. General statistical reasoning distinguishes a within-group outcome from a comparative treatment effect: the first describes what was observed, while the second asks how outcomes differ between strategies under a comparison design. The registry record reports no comparative estimate.
The record also illustrates the importance of clearly reporting analysis populations and missing follow-up. Enrollment is listed as 13, while the safety denominators are 9. Without an explanation of those denominators or an outcome-specific analysis population, readers cannot determine how the participant counts relate across outcomes. This is a reporting limitation, not evidence that any particular participants were excluded or that data were missing.
Finally, the safety entries distinguish serious from other adverse events, but provide little detail beyond affected counts. Statistical interpretation depends on denominators and on the way events were defined and collected. Those details are not reported in the registry record. Taken together, these features show how study design, endpoint reporting, uncertainty, and analysis-population transparency constrain what can be concluded from a registry record. The study's termination status adds context, but without a reported reason it cannot explain the absence of outcome analyses.
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 record gives limited detail about eligibility. The official title identifies intermediate-risk adenocarcinoma of the endometrium, while the condition is listed as uterine cancer. Further eligibility criteria, disease characteristics, and the basis for risk classification are not reported in the registry record. This restricts assessment of how specifically the enrolled group is characterized.
The intervention is named as a paclitaxel and carboplatin combination, but dose, administration schedule, planned duration, treatment modifications, and adherence are not reported in the registry record. Those details are relevant to describing the treatment actually received, but cannot be inferred from the intervention name.
The primary endpoint description does not provide detailed event criteria or analysis rules. Although the record specifies disease-free survival, a median, a full range, and a timeframe, it does not report the median or range. The number of outcome events, censoring rules, follow-up completeness, and confidence interval are also not reported in the registry record. Median follow-up alone does not resolve these gaps.
The record lists enrollment of 13, but gives safety at-risk denominators of 9. It does not explain the denominator difference or identify the analysis population for the primary endpoint. Missing-data methods, participant flow, and reasons for non-inclusion are not reported in the registry record. The absence of a comparator further limits comparative interpretation, and the reason for termination is not reported.
Finally, no statistical analysis is reported in the registry record. The sample-size justification, prespecified hypotheses, analysis model, multiplicity plan, and any interim analyses are not reported. No claims about those design features can be made from the registry entries. These limitations mean the posted record offers a partial account of the study rather than a complete statistical report.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus — NCT00584909.
- Registry record last updated 2017-01-27; status last verified 2017-01.
- Results first posted 2012-03-29.
- 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
The registry identifies NCT00584909 as a Phase II study of paclitaxel and carboplatin in patients with intermediate-risk adenocarcinoma of the endometrium. University of Alabama at Birmingham is listed as sponsor. The study started in 2006-03, had a primary completion date of 2010-09, and is listed as terminated. Enrollment is recorded as 13.
The design is single group, open label, with no masking and no comparator reported. Disease-free survival, summarized by its median in months, is the primary outcome; toxicity is listed as secondary. The record gives a median follow-up time of 45.3 months but no primary-outcome estimate or analysis. It reports 0 serious adverse events among 9 at risk and other adverse events affecting 9 of 9 at risk. Analysis details, missing-data handling, and the reason for termination are not reported in the registry record.