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 Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma (NCT00418093), a na phase 2 study. The primary outcome is Partial Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00418093 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dana-Farber Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned women with recurrent Mullerian carcinoma. The registry lists ovarian cancer, fallopian tube cancer and primary peritoneal cancer as conditions. It records 19 participants enrolled. The record does not describe further eligibility criteria or characteristics of the participants, so the population represented cannot be defined more narrowly from this information.
Intervention
The regimen combined oxaliplatin, gemcitabine and bevacizumab. The arm description says all patients received all three drugs. Specific doses, administration schedules, treatment modifications and rules for stopping treatment are not reported in the registry record.
Comparator
There was no separate comparison group: the trial is identified as single-group, with allocation listed as NA. It therefore does not provide a randomized, like-for-like estimate comparing the regimen with another treatment or with no treatment. Any interpretation is limited to outcomes recorded among participants receiving the combination.
Primary question
The primary endpoint was partial response rate, expressed as the percentage of patients on study. Response was determined by RECIST criteria. In general, a response criterion gives investigators a standardized way to classify changes in disease; it is not itself a comparison with another treatment. The registry describes assessment every 2 cycles (every 8 weeks) during time on study, with an average of 4.5 cycles (18 weeks). The observed response rate is not reported in the registry record. Secondary questions concerned progression-free survival, overall survival and the nature and degree of toxicities.
3. Trial Design
This was a Phase II, single-group trial sponsored by Dana-Farber Cancer Institute. The registry lists 19 participants enrolled and identifies the status as terminated. The recorded start is 2006-09, and primary completion is listed as 2011-01. The reason for termination is not reported in the registry record.
The study had no masking. Its single chemotherapy arm included oxaliplatin, gemcitabine and bevacizumab; the arm description states that all patients received the combination. Allocation is listed as NA, consistent with the single-group design rather than a randomized allocation between treatment arms. There is therefore no internal control group for separating treatment-associated outcomes from changes that might occur over time or from other influences.
The primary endpoint was partial response rate, with response determined using RECIST criteria. The stated assessment schedule was every 2 cycles (every 8 weeks) for the duration on study, which averaged 4.5 cycles (18 weeks). The registry also identifies progression-free survival and overall survival, along with assessment of the nature and degree of toxicities, as secondary outcomes. Detailed definitions and analysis procedures for those outcomes are not reported in the registry record.
The record does not report the regimen's doses, eligibility details, baseline participant characteristics, or the reason the study ended. It also does not report a protocol-based sample-size justification or the statistical analysis plan. Without those details, the design can be described at the level of its phase, treatment group, masking, enrollment and listed outcomes, but not reconstructed in greater operational detail.
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 | Chemotherapy Group |
|---|---|
| STARTED | 19 |
| Completed Study | 19 |
| COMPLETED | 19 |
| NOT COMPLETED | 0 |
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 | Group 1 |
|---|---|---|
| Participants analysed | 19 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 14 |
| Age, Categorical: >=65 years | Participants | 5 |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Partial Response Rate, measured over Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of patients on study |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was partial response rate, described as the percentage of patients on study who responded to the treatment regimen. Response was determined by RECIST criteria. In general, an endpoint of this kind converts individual response classifications into a proportion for the defined analysis population. It can describe how frequently a particular response classification occurred in the group studied, but it does not by itself establish how that frequency compares with another treatment.
The registry states that response was assessed every 2 cycles (every 8 weeks) for the duration on study, averaging 4.5 cycles (18 weeks). Thus, the endpoint was monitored over treatment rather than at one single assessment time specified for every participant. The registry does not provide the response count, percentage, confidence interval, or details about which assessment determined a participant's final response classification. The primary response result is not reported in the registry record.
Response is used as a clinical-trial endpoint because it gives a defined way to describe tumor response during treatment. In general, standardized criteria can make outcome classification more consistent, but the resulting proportion remains dependent on the population and endpoint rules used. It is not a direct measure of survival, and it is not a comparative treatment effect in this single-group study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a Phase II study of a three-drug regimen in 19 enrolled participants with recurrent Mullerian carcinoma. Its main endpoint was partial response rate, assessed using RECIST criteria. However, the registry record does not report the number or percentage of participants who had a partial response. Consequently, the primary endpoint cannot be quantified from the recorded results, and there is no posted response estimate to interpret for magnitude or precision.
The study's single-group design is central to interpretation. Outcomes among participants receiving the combination can be described, but there is no separate control group in this trial for a direct treatment comparison. Even if the response result were available, a response proportion from one group would not by itself show what would have happened to comparable participants under another treatment or without the regimen. The posted information therefore does not establish a comparative effect.
The registry lists progression-free survival and overall survival as secondary outcomes, but their results are not reported in the registry record. It also lists toxicity assessment. For safety, the adverse-event record identifies 19 participants at risk for other adverse events, with 19 affected, and 19 at risk for serious adverse events, with 1 affected. Thrombosis/thrombus/embolism is listed among the serious adverse-event terms at 5.3%. These entries describe recorded safety counts and a listed term; they do not establish that the regimen caused an event. The record does not give additional clinical detail about the events or their timing.
The trial is marked terminated, but the reason is not reported in the registry record. Termination alone does not explain whether the study ended for administrative, operational, safety, efficacy or other reasons. The record also does not report a sample-size justification or a statistical analysis plan. Those omissions limit assessment of how the study's outcomes were intended to be estimated and interpreted.
Overall, the available registry information supports a description of the design, treatment, scheduled response assessments and selected adverse-event entries. It does not support a numerical conclusion about the primary response endpoint, survival outcomes, or comparative benefit. Absence of a reported result should not be interpreted as evidence of either a favorable or an unfavorable result.
9. Statistical Methods Explained
The design determines what statistical claims the study can support. This was a single-group, unmasked Phase II trial, not a randomized comparison. Participants received the combination of oxaliplatin, gemcitabine and bevacizumab. In general, a single-group study can estimate outcomes observed in that group, but it cannot directly estimate a between-group treatment contrast because no concurrent comparator group is described. Differences from other studies would not be randomized comparisons within this trial.
What does the response endpoint represent?
The primary outcome is a response proportion: a percentage of patients on study classified as having a partial response according to RECIST criteria. In general, estimating a proportion involves identifying the number classified as responders and the population used as its denominator. The registry record does not report either the response count or the response percentage, and it does not describe the analysis population in detail. Thus, no response estimate can be independently interpreted from the posted outcome information.
Assessments were scheduled every 2 cycles (every 8 weeks) while participants remained on study; the average duration was 4.5 cycles (18 weeks). In general, repeated assessments raise questions about how results across visits are combined into a participant-level endpoint, including how missing or unevaluable assessments are handled. Those endpoint rules are not reported in the registry record. The assessment schedule alone does not establish whether the primary analysis used best response, a particular visit, or another rule.
How should precision be understood?
In general, a confidence interval communicates the uncertainty around an estimated quantity, such as a response proportion. A narrower interval indicates greater statistical precision under the method used; a wider interval indicates less precision. The interval also depends on the endpoint definition, analysis population and statistical procedure. No confidence interval for the primary response rate is reported in the registry record, so its precision cannot be assessed. The enrolled total of 19 describes study enrollment, but does not by itself identify how many participants were included in a specific endpoint analysis.
A p-value, in general, evaluates how compatible observed data are with a specified statistical null model. It does not measure the size or clinical importance of an effect. No primary endpoint p-value or inferential analysis is reported in the registry record. Because the design has no comparison arm, a p-value cannot substitute for a missing concurrent comparator or resolve the limitations of a single-group estimate.
What does the planning illustration imply?
The planning framework is an illustration, not a description of the trial's own design or an observed-power calculation. It is based on a two-sided significance level of 0.05, equal allocation between two hypothetical arms and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. The framework distinguishes participants per arm for non-time-to-event outcomes from total event counts for time-to-event outcomes. These assumptions do not turn this single-group trial into a two-arm study. A protocol sample-size justification is not reported in the registry record, and the posted primary response result needed to anchor an observed-effect illustration is also not reported.
In general, planning calculations answer a prospective question: how much information might be needed under chosen assumptions. They do not show what the trial observed, and they do not establish the probability that a result is true. If a planning illustration is based on an observed effect, that effect and the assumptions used to scale it matter. The registry information does not report a trial-specific design justification, so the illustration should not be read as evidence that enrollment was selected to achieve a stated power for this study.
Which analysis choices remain unknown?
The registry identifies the primary endpoint and some secondary outcomes, but the statistical analysis plan is not reported in the registry record. In particular, the record does not specify confidence-interval methods, hypothesis tests, covariate adjustment, analysis populations, or rules for censoring and missing observations. These choices can affect both the estimate and its interpretation. The record also does not explain whether an interim analysis was planned or performed; no such plan should be inferred from the trial's status.
For time-to-event outcomes such as progression-free survival and overall survival, general statistical methods often account for follow-up time and censoring, rather than treating every participant as having the same observation period. The registry names these outcomes but does not report definitions, event counts, estimates or analysis procedures. Therefore, no time-to-event result or precision assessment can be reconstructed. The same caution applies to toxicity: the adverse-event counts are descriptive entries, not a complete account of a statistical comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes: partial response rate as the primary endpoint, and progression-free survival, overall survival and toxicity assessment as secondary outcomes. When multiple outcomes or repeated tests are considered, multiplicity can increase the chance of at least one apparently notable finding by chance. In general, a prespecified testing hierarchy or adjustment method can clarify how such findings are interpreted. No multiplicity strategy or hierarchy is reported in the registry record, so it is not possible to determine how the outcomes were handled together.
The response outcome was assessed every 2 cycles (every 8 weeks) during time on study. Repeated measurement makes the endpoint rule important: a report should clarify whether response is based on a particular visit or a participant-level summary across visits. That rule is not reported. Neither the analysis populations nor the treatment of participants with missing, unevaluable or incomplete assessments is reported in the registry record. The listed enrollment of 19 should not be assumed to be the denominator for every outcome.
The registry does not describe an intention-to-treat, per-protocol or safety analysis population, and it does not provide a missing-data method. For survival outcomes, censoring rules and follow-up definitions are also not reported. These gaps make it difficult to assess whether the analyzed participants and observations were determined consistently with a prespecified plan. No interim-analysis plan or result is described 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 |
|---|---|---|---|
| Group 1 | 1 | 19 | 5.3% |
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 |
|---|---|
| Group 1 | 19 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1 |
|---|---|---|
| Thrombosis/thrombus/embolism | Vascular disorders | 1 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1 |
|---|---|---|
| Fatigue | General disorders | 7 of 19 |
| Neutropenia | Blood and lymphatic system disorders | 6 of 19 |
| Neuropathy | Nervous system disorders | 5 of 19 |
| Nausea/Vomiting | Gastrointestinal disorders | 5 of 19 |
| Hypertension | Cardiac disorders | 2 of 19 |
| Allergic Reaction to Oxaliplatin | Immune system disorders | 1 of 19 |
Serious events with the highest arm-level rate: thrombosis/thrombus/embolism (5.3%).
The adverse-event entry identifies 19 participants at risk for serious adverse events, with 1 affected. For other adverse events, it lists 19 at risk and 19 affected. These are participant counts in the registry's safety group, not measures of severity beyond the serious-versus-other categories indicated in the record. The serious-event term listed at the top is thrombosis/thrombus/embolism at 5.3%.
These figures describe what the registry records; they do not establish that the treatment caused an event. The record does not provide event timing, duration, clinical details, recurrence, relationship to treatment, or a complete breakdown of all event types in the information available. The listed term should therefore be read as a reported safety category, not as an explanation of its circumstances. The registry does not report a comparative safety group, so these counts cannot provide a randomized comparison of event frequency between treatments.
Participant counts and event counts are not interchangeable in general: one participant may experience more than one event, while an affected-participant count records whether participants were affected. The entries are labeled as affected participants. No further interpretation of severity or causality is justified by those counts alone.
12. What the Result Does, and Does Not, Mean
The record establishes that this was a Phase II, open-label, single-group study of oxaliplatin, gemcitabine and bevacizumab in women with recurrent Mullerian carcinoma. It records 19 participants enrolled, identifies partial response rate as the primary endpoint and states that response was determined by RECIST criteria. It also records scheduled assessments every 2 cycles (every 8 weeks), averaging 4.5 cycles (18 weeks) on study.
What the record does not establish is the observed partial response rate. That outcome is not reported in the registry record, and neither a confidence interval nor a comparative treatment estimate is available. Progression-free survival and overall survival are listed as secondary outcomes, but their results are not reported either. The absence of these results cannot be interpreted as evidence that participants did or did not respond, or that the regimen did or did not affect survival.
The safety information identifies serious and other adverse-event counts and lists thrombosis/thrombus/embolism at 5.3% among the serious terms. Those records describe observed safety entries, but the information does not establish causation or provide enough detail to characterize clinical context. Because there is no separate control group, the trial also cannot make a randomized comparison of adverse events.
The study's termination status does not explain why it ended; the reason is not reported in the registry record. Nor does the record report the analysis plan, endpoint analysis population, missing-data handling or protocol sample-size justification. These omissions mean the design and reported counts can be described, but important aspects of result interpretation remain unresolved. The trial record should be read as an incomplete account of the outcomes rather than as a basis for a conclusion about comparative efficacy or safety.
13. Why This Trial Matters Statistically
This trial illustrates how a clearly named endpoint does not guarantee that an interpretable endpoint result is available. The registry identifies partial response rate, the response criteria and an assessment schedule, but does not report the response count or percentage. Without the estimate, readers cannot judge its magnitude or statistical precision, even though the outcome is defined at a high level.
It also illustrates the distinction between describing outcomes in a single group and estimating a comparative effect. All patients in the described arm received the three-drug combination, and no randomized comparator is identified. A single-group response proportion, if reported, would describe the studied group; it would not by itself identify what would have happened under another treatment. This is a design limitation, not a flaw that can be resolved by interpreting the percentage more strongly.
The registry's safety counts demonstrate another statistical distinction: counts of affected participants are descriptive and do not establish treatment causality. The record includes one participant affected by a serious adverse event among 19 at risk, and it lists a serious-event term at 5.3%. Without clinical detail, timing, attribution and a control group, these entries cannot answer broader comparative safety questions.
Finally, a terminated status and a planned assessment schedule do not replace the missing analysis details. Definitions of analysis populations, handling of missing observations, multiplicity procedures and reasons for termination all matter when interpreting clinical-trial evidence. Their absence limits what can be concluded from the registry entry. The statistical lesson is to separate what the record documents from what would require results or design information that it does not report.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial is that the primary response result is not reported in the registry record. The response count, percentage and precision are unavailable, so the central endpoint cannot be evaluated quantitatively. Results for the named secondary outcomes, progression-free survival and overall survival, are also not reported.
The single-group design has no concurrent treatment comparator, and masking is listed as none. This limits comparative interpretation and leaves outcomes open to influences that a randomized control group might help address. The registry lists 19 participants enrolled, but does not report how many were included in each endpoint analysis or how the analysis populations were defined.
Important implementation and analysis details are absent: eligibility criteria beyond the disease conditions, participant characteristics, drug doses and schedules, response aggregation rules, missing-data handling, survival definitions, censoring procedures, multiplicity strategy and statistical analysis plan. A protocol sample-size justification and the reason for termination are not reported in the registry record. The assessment schedule and average time on study do not resolve these omissions.
The safety entries provide affected-participant counts and one listed serious-event term, but not event timing, treatment attribution, detailed clinical descriptions or a comparative group. Consequently, they support only a limited descriptive account. These limitations should not be filled by assumptions about why the study ended, how outcomes were analyzed or what unreported results might have been.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma — NCT00418093.
- Registry record last updated 2014-06-19; status last verified 2014-06.
- Results first posted 2014-06-19.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a Phase II, open-label, single-group study of oxaliplatin, gemcitabine and bevacizumab in women with recurrent Mullerian carcinoma. Dana-Farber Cancer Institute is listed as sponsor. Enrollment is 19; the recorded start is 2006-09, primary completion is 2011-01, and status is terminated.
Partial response rate was the primary endpoint, with response determined by RECIST criteria and assessment every 2 cycles (every 8 weeks) during time on study, averaging 4.5 cycles (18 weeks). Progression-free survival, overall survival and toxicity were secondary outcomes. The primary response result and secondary outcome results are not reported in the registry record.
The safety entry records 1 participant with a serious adverse event among 19 at risk and 19 participants with other adverse events among 19 at risk. Thrombosis/thrombus/embolism is listed at 5.3% among serious terms. The study has no comparison group, and the reason for termination is not reported.