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 Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer (NCT00354601), a na phase 2 study. The primary outcome is Objective Tumor Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00354601 |
| Phase | Phase 2 |
| Condition | Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The intended population was patients with persistent or recurrent platinum-resistant epithelial cancer of the ovary, fallopian tube, or peritoneum. The registry lists ovarian cancer, fallopian tube cancer, and peritoneal cavity cancer as conditions. The primary-outcome description refers to evaluable patients, but the registry does not report further eligibility or evaluability details in the outcome record.
Intervention
The study arm is described as weekly docetaxel and capecitabine. Both drugs are listed as interventions. The record does not provide dose, schedule detail beyond weekly treatment, treatment duration, or information about dose modifications.
Comparator
This was a single-group study, not a randomized comparison. No concurrent control arm is listed, so the treatment experience cannot be contrasted directly with another regimen within this trial. The sample-size planning assumptions describe a hypothetical equal-allocation comparison; they do not change the single-group design.
Primary question
The primary outcome was objective tumor response at 8 weeks: the number of complete and partial responders among evaluable patients, defined using Response Evaluation Criteria in Solid Tumors guidelines. The registry says this outcome was unable to be measured due to failure to complete. It therefore does not provide a response estimate for addressing the primary question.
3. Trial Design
The registry describes NCT00354601 as a phase II, single-group study sponsored by Wake Forest University Health Sciences. Its title concerns docetaxel and capecitabine in patients with recurrent or persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. The official title further characterizes the intended disease as platinum-resistant epithelial carcinoma. Allocation is listed as not applicable, and masking is listed as none. These features describe an open-label, nonrandomized treatment study rather than a blinded controlled trial.
The listed arm, Weekly Docetaxel and Capecitabine, has the same treatment description as the intervention. Capecitabine and docetaxel are both listed as drugs. Although the brief rationale contains a sentence about docetaxel together with carboplatin, the stated purpose and the listed arm and interventions concern docetaxel together with capecitabine. This difference within the registry record makes the rationale text internally inconsistent; it does not establish that carboplatin was administered.
Enrollment is recorded as 2. The study status is terminated, with a start date of 2006-01 and primary completion recorded as 2008-05. The registry does not report the reason for termination, the number who began treatment, or the number who completed treatment. The primary-outcome population is described as unable to be measured due to failure to complete. That statement signals that the intended response assessment was not obtained as planned, but it does not identify which participants failed to complete or why.
Time to progression, grade 3 or higher toxicity, and quality of life are listed as secondary outcomes. The record lists four outcome measures overall, but does not report analyses for any of them. Details such as treatment dose, follow-up schedule, eligibility criteria, and the planned analysis methods 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 | Docetaxel and Capecitabine |
|---|---|
| STARTED | 2 |
| COMPLETED | 0 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Docetaxel and Capecitabine |
|---|---|
| Protocol Violation | 1 |
| progression | 1 |
Analysis population for the primary outcome, as defined in the registry: unable to measure due to failure to complete
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 | Docetaxel and Capecitabine |
|---|---|---|
| Participants analysed | 2 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 1 |
| Age, Continuous | years | 60.15 (SD 8.84) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Tumor Response, measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is objective tumor response at 8 weeks. It is defined as the number of complete and partial responders among all evaluable patients, using Response Evaluation Criteria in Solid Tumors guidelines. In general, an objective response endpoint classifies tumor change according to prespecified criteria. It can provide a structured way to describe whether tumors meet response categories during a defined assessment period, rather than relying only on an unstructured clinical impression.
The endpoint is not a time-to-event measure: it focuses on response status at a stated assessment time. The registry does not give a response count, the number of evaluable patients, or a response proportion. Instead, it says that the outcome was unable to be measured due to failure to complete. As a result, the primary endpoint cannot be used to estimate the frequency of complete or partial response in this trial.
The endpoint description refers to evaluable patients, while also saying the number of responders is among all evaluable patients. The precise analysis population and rules for evaluability are not reported in the registry record. The listed secondary outcomes address progression, toxicity, and quality of life, but their measures and results are not reported in the registry record. Thus, the endpoint definition clarifies the intended clinical question, but it does not supply an observed response result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record describes a small, terminated, single-group phase II study with enrollment of 2. Its primary outcome is objective tumor response at 8 weeks, but the registry explicitly states that the outcome was unable to be measured due to failure to complete. There is consequently no posted response count or response estimate to interpret. The absence of a measurable endpoint is not evidence that response did or did not occur; it means the registry record does not provide the information needed to quantify the primary outcome.
Interpretation is also constrained by the study design. With one treatment group and no randomized comparator, the design does not provide a within-trial estimate of how outcomes would differ under another treatment. Even if response data were available, a single-group result would describe outcomes among the observed participants and would not by itself separate treatment-associated outcomes from other influences. The small recorded enrollment further limits what can be learned from the participants who entered the study; it does not support broad conclusions about the intended population.
The adverse-event record lists 1 participant with a serious adverse event and 2 with other adverse events for the Docetaxel and Capecitabine group. It also identifies rash: hand-foot skin reaction at 50.0% among the top serious terms. The registry does not report the number at risk for these event categories, and the available fields do not make the denominator for the percentage clear. These entries should therefore be read as the recorded safety information, not as rates with a confirmed denominator. The group-level counts also cannot establish the timing, duration, severity beyond the listed classification, or causal relation of each event.
Time to progression, grade 3 or higher toxicity, and quality of life appear as secondary outcomes, but results and analyses are not reported in the registry record. There are no reported analysis entries. Consequently, neither the primary question nor the listed secondary questions can be resolved from the posted results. The registry record also does not state why the study was terminated or whether incomplete assessments arose from withdrawal, logistical issues, or another cause. Those possibilities should not be inferred.
The planning illustrations should be understood as hypothetical sample-size calculations, not as trial results or observed power. Their assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of the observed effect. The study itself is single-group, so those hypothetical assumptions are not a description of its actual design. Moreover, the registry does not provide a measurable primary outcome effect to interpret as an observed response effect. Planning quantities cannot replace missing outcome data or establish that a study had a particular probability of detecting an effect.
The brief summary contains a mismatch: its rationale refers to docetaxel with carboplatin, while its purpose and the listed interventions describe docetaxel with capecitabine. The arm description and intervention list align with the latter. The record does not explain this inconsistency, so it cannot be resolved by assuming a different administered regimen. Overall, the posted information chiefly describes the intended question and the fact that its primary outcome could not be measured, rather than providing evidence about response or comparative effectiveness.
9. Statistical Methods Explained
What does a single-group design estimate?
In general, a single-group study records outcomes among participants receiving the listed intervention, without a concurrent control group. It can describe observed outcomes within that group if the outcomes are collected and reported. It cannot, on its own, make a randomized comparison between the intervention and an alternative. Differences from other studies or historical experience would require additional assumptions and are not part of a randomized contrast in this record. Here, the registry lists a single group receiving weekly docetaxel and capecitabine and does not list a control arm.
Allocation is marked not applicable and masking is listed as none. In general, random allocation is used to create treatment groups whose differences are not systematically determined by treatment assignment, while masking can reduce the influence of knowledge about treatment on care or assessment. Neither a randomized contrast nor masking is described for this study. The registry does not report further procedures that might address these concerns.
What does the response endpoint represent?
Objective response is a categorical endpoint based on tumor assessment criteria. The registry specifies complete and partial responders under Response Evaluation Criteria in Solid Tumors guidelines, assessed at 8 weeks. In general, a categorical endpoint requires both a clear outcome definition and an identified analysis population. The definition gives the response categories and timing, but the registry does not provide the number assessed, the number responding, or the operational rules for evaluability.
Because the recorded result says the endpoint was unable to be measured due to failure to complete, an estimate of response cannot be reconstructed from the record. Statistical summaries such as a response proportion or its uncertainty would require numerator and denominator information. No such calculation should be substituted for the registry’s statement. The result is missing as a measurable endpoint, rather than a zero response result.
How should the safety entries be read?
The adverse-event record separates serious adverse events from other adverse events and lists group-level counts. It records 1 participant with a serious adverse event and 2 with other adverse events. The entry for rash: hand-foot skin reaction is 50.0% among the top serious terms. In general, an event count describes how many participants or events meet a defined category, while a rate or percentage requires a denominator and a clear unit of analysis. The at-risk denominators are not reported in the record, and it is not clear from these entries whether a percentage refers to participants, events, or another basis. The percentage therefore should not be converted into a participant count or treated as a precisely interpretable incidence rate.
Safety summaries also depend on ascertainment rules, observation periods, and whether repeated events are counted by participant or event. These details are not reported in the registry record. The entries support only a limited description of what was recorded; they do not characterize the full safety profile or establish that an event was caused by treatment.
What can sample-size planning tell readers?
In general, sample-size planning estimates how many observations might be needed to detect a specified effect under stated assumptions. A significance level sets a criterion for evidence against a null hypothesis, while a power target concerns the probability of detecting a particular assumed effect if that effect is true. A planning calculation is conditional on its inputs, including outcome variability, effect size, allocation, and analysis method. It is not a measure of what a completed study actually achieved.
The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They state that the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the planning description refers to a total number of events; for other outcomes, it refers to participants per arm. These are planning conventions, not observed participant counts or results from the single-group trial. In particular, hypothetical two-arm allocation does not describe the actual study design.
The record does not provide a measurable primary response effect that could ground interpretation of such planning quantities. Nor does it report a sample-size justification for the trial’s own design. Any planning illustration should be understood as an assumption-based translation, not evidence that the study was adequately sized, that a target power was attained, or that a treatment effect was observed. “Observed power” is not a substitute for interpreting the outcome estimate and its uncertainty; in this case, the primary estimate is not reported as measurable.
What is the role of confidence intervals and over-dispersion?
In general, a confidence interval describes a range of values compatible with data under a specified statistical model and procedure. Its width reflects uncertainty, which depends on the amount and structure of information as well as the model. A narrow interval indicates greater precision than a wide interval under the same framework, but neither width nor statistical significance alone establishes clinical importance. No confidence interval for the primary endpoint is reported in the registry record, because the outcome could not be measured.
Over-dispersion is a general issue in count data: observed variation can exceed what a simple count model assumes. If it is present and ignored, standard errors and intervals may be miscalibrated. It is not reported whether over-dispersion was assessed or whether count models were used in this study. Since no analysis entries are reported, readers cannot determine which statistical model, if any, was applied to the listed secondary outcomes.
What analyses are documented?
The registry record lists no analysis entries. It does not report a statistical analysis plan, hypothesis tests, adjustment variables, interim analyses, missing-data methods, or procedures for multiple outcomes. This lack of documentation does not establish that investigators did not make such plans or conduct analyses outside the registry; it means those details are not reported in the registry record. Interpretation should therefore remain anchored to the posted endpoint definitions, status, and results rather than attributing an unreported method to the investigators.
10. Multiplicity, Missing Data and Analysis Populations
The record lists objective tumor response as the primary outcome and identifies time to progression, grade 3 or higher toxicity, and quality of life as secondary outcomes. Four outcome measures are listed overall, but no analyses are reported. The registry does not state whether the outcomes were organized into a testing hierarchy, whether any adjustment for multiple testing was planned, or how secondary outcomes would be interpreted if several were examined. In general, assessing multiple outcomes can increase the chance of finding an apparently notable result by chance when each is tested separately. A prespecified multiplicity strategy can help define how evidence across outcomes should be interpreted. No such strategy is reported in the registry record.
Missingness is central to the primary outcome because the registry says it was unable to be measured due to failure to complete. The record does not specify how many participants lacked an assessment, the reason for noncompletion, the timing of missingness, or whether any outcome data were collected before completion failed. It does not describe imputation, censoring, or a sensitivity analysis. In general, missing-data methods rely on assumptions about why data are unavailable; without details on the pattern and reason, the impact of missingness on an estimate cannot be evaluated.
The primary endpoint refers to evaluable patients, but the registry does not define the analysis population in greater detail. It does not report whether all enrolled participants were included in any analysis or how participants who did not complete were handled. The analysis population for the secondary outcomes is also not reported in the registry record. These gaps prevent assessment of how the intended population, enrolled participants, and analyzed participants relate to one another.
11. What the Result Does, and Does Not, Mean
The registry record establishes the intended treatment question: a phase II study of weekly docetaxel and capecitabine for persistent or recurrent platinum-resistant epithelial cancer of the ovary, fallopian tube, or peritoneum. It also establishes that enrollment was 2, the study was terminated, and the primary response endpoint was unable to be measured due to failure to complete. These registry entries describe the conduct and reporting status of the study; they do not provide an estimate of tumor response.
The result does not show that no participants responded. It also does not show that participants responded. A statement that an endpoint could not be measured means that the registry does not contain a usable measurement for that outcome. Without a response count, denominator, and analysis, neither the frequency nor precision of response can be characterized. The listed secondary outcomes likewise cannot fill that gap because their results are not reported in the registry record.
The safety entries record 1 participant with a serious adverse event and 2 with other adverse events, and list rash: hand-foot skin reaction at 50.0% among the top serious terms. They do not, on their own, establish event rates with a known denominator, treatment causality, or a complete account of harms. The record does not report at-risk denominators or enough methodological detail to establish the basis of the percentage.
Because this is a single-group study, its record does not provide a randomized comparison against another treatment. The hypothetical assumptions used for planning illustrations are not a substitute for a control group and are not evidence of an observed treatment effect. In general, planning calculations express the sample size that would follow from selected assumptions; they do not tell whether an effect occurred or how precisely it was estimated.
The appropriate interpretation is therefore limited: the registry documents a planned response question, but reports that the primary endpoint could not be measured. The posted results do not establish benefit, lack of benefit, comparative performance, or a definitive safety profile. Those conclusions would require outcome information and analytic details that are not reported in the registry record.
12. Why This Trial Matters Statistically
This study is statistically informative in an important way: it distinguishes a stated clinical question from an answerable outcome result. A trial may have a defined endpoint and assessment time, yet still lack a measurable result in its registry record. Here, objective tumor response was specified using Response Evaluation Criteria in Solid Tumors at 8 weeks, but the record says the outcome could not be measured due to failure to complete. That distinction prevents an unavailable result from being misread as a finding of no response.
The case also illustrates why design and analysis populations matter. The study was single-group, while its planning assumptions refer to hypothetical equal allocation between two arms. Those assumptions should not be mistaken for the actual study design. A planning calculation may help express what would be needed under selected assumptions, but it cannot supply a missing comparator or make an unmeasured endpoint interpretable.
Safety summaries also require attention to denominators. Counts and percentages can appear precise, yet their meaning depends on who was observed, the event definitions, and the unit counted. The available adverse-event entries list counts and a percentage but do not report the at-risk denominators. Recognizing that limitation is part of reading a registry result responsibly, rather than treating every percentage as a comparable rate.
Finally, the record demonstrates the importance of consistent trial descriptions. Its brief rationale mentions carboplatin, whereas the stated purpose and listed interventions specify capecitabine with docetaxel. The record does not resolve that inconsistency. Describing it explicitly avoids quietly assigning an intervention that the arm and intervention listings do not support. Together, these features make the study a useful example of how careful interpretation depends not only on statistical methods, but also on endpoint completion, population definitions, denominator transparency, and coherent reporting.
13. 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 is that the primary outcome is reported as unable to be measured due to failure to complete. There is no response count, evaluable-patient denominator, or response estimate. The registry does not explain why completion failed, how many participants were affected, or whether any response assessments were available before the failure. This prevents evaluation of the intended primary endpoint and of the possible influence of missing assessments.
The recorded enrollment is 2, and the study is terminated. The registry does not report why it was terminated or how many participants received treatment or completed follow-up. The very limited enrollment information means the record cannot support a stable characterization of outcomes in the intended population. No comparative control group is listed, so the design would not support a randomized comparison even if outcome data were available.
The available safety entries have incomplete denominator information. The record lists 1 participant with a serious adverse event and 2 with other adverse events, but does not report the numbers at risk. The 50.0% entry for rash: hand-foot skin reaction is not accompanied by a clear denominator in the available record. Event timing, duration, attribution, and ascertainment details are also not reported.
Other limitations include the absence of reported analyses for the primary and secondary outcomes, no detailed analysis population definition, and no reported methods for missing data or multiplicity. The registry does not report dose details, eligibility criteria, or the reason for the inconsistency between the rationale’s reference to carboplatin and the capecitabine regimen named in the purpose and intervention listings. These are limitations of what can be concluded from the registry record; they should not be treated as proof that additional information does not exist elsewhere.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer — NCT00354601.
- Registry record last updated 2017-08-30; status last verified 2017-03.
- Results first posted 2009-05-18.
- 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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17. Record Summary
NCT00354601 is a phase II, single-group study sponsored by Wake Forest University Health Sciences. It was intended to examine weekly docetaxel and capecitabine for persistent or recurrent platinum-resistant epithelial cancer of the ovary, fallopian tube, or peritoneum. Enrollment is recorded as 2; the study status is terminated.
The primary outcome was objective tumor response at 8 weeks, defined by complete and partial responses under Response Evaluation Criteria in Solid Tumors. The registry states that this outcome was unable to be measured due to failure to complete. Time to progression, grade 3 or higher toxicity, and quality of life are listed as secondary outcomes, but analyses are not reported. Safety entries include 1 participant with a serious adverse event, 2 with other adverse events, and rash: hand-foot skin reaction at 50.0% among the top serious terms; denominators are not reported. The record does not provide a measurable primary response result or a randomized comparison.