TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary (NCT00296816), a non-randomized phase 2 study. The primary outcome is Twelve-month Progression-free Survival (PFS) Rate in Participants.

2. Clinical Question

The clinical question is therefore about the 12-month progression-free survival rate observed in a defined group receiving the three-drug combination, not about whether the combination outperformed another treatment. The study included people with several related cancer diagnoses and stages, but the primary endpoint population excluded participants from the prematurely closed site when efficacy data were unavailable. That distinction matters: the enrollment figure and the population used for the primary endpoint are not interchangeable.

The record also lists outcomes concerning progression-free survival over a longer period, tumor response, recurrence-free survival in participants without measurable disease at baseline, CA-125 response and overall survival. These are additional questions, not substitutes for the primary endpoint. The registry does not report their results in the information recorded for this analysis. Consequently, the record supports a description of what the trial set out to evaluate, but not a numerical conclusion about the endpoint or a comparison of treatment effects.

3. Trial Design

This was a phase II, non-randomized, single-group study with no masking. The registry lists an enrollment of 132 and identifies Sanofi as the sponsor. The study status is completed. Its recorded start was 2006-03, and primary completion was 2011-08. These administrative details describe the registered study; they do not provide a treatment-effect estimate.

The intervention group received oxaliplatin, docetaxel and bevacizumab. The population description includes participants with FIGO stage IB through IV ovarian, primary peritoneal or fallopian tube carcinoma. Treatment is described as occurring 28 days after initial surgery. The registry characterizes the study as first-line therapy and identifies feasibility as a central purpose, including assessment of the combination and the concurrent addition of bevacizumab.

Because there was one treatment group and no random allocation, the study does not make a randomized, concurrent comparison between the combination and an alternative. Outcomes observed in the group can describe what happened among participants included in the relevant analysis population. Without a comparison group, differences attributable to treatment cannot be separated from other explanations through a randomized contrast. The design also does not establish how outcomes would compare with a different regimen or with no study treatment.

The primary endpoint population was defined as an intent-to-treat population with measurable disease at baseline among those who received study drugs, with an exception for participants at one site that closed prematurely and for whom efficacy data were unavailable. The record does not report the number in that specific population. The enrollment of 132 should therefore not be assumed to be the denominator for the primary endpoint. The record also does not report the treatment schedule beyond the timing relative to surgery, the detailed conduct of follow-up, or the statistical plan used to analyze the endpoints.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.

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.

6. Primary Endpoint

The registry lists the primary outcome as Twelve-month Progression-free Survival (PFS) Rate in Participants, measured over up to 12 months following treatment initiation.

The primary endpoint was the 12-month progression-free survival rate, expressed as a percentage of participants. It was intended to describe the proportion of the defined population who did not die or show disease progression up to 12 months following treatment initiation. The registry describes progression assessment using computed tomography and magnetic resonance imaging, applying Gynecologic Oncology Group response evaluation criteria in solid tumors.

Progression could be recorded through the appearance of a new lesion, symptomatic deterioration, progression of target or nontarget lesions, or death. Thus, the endpoint combines imaging findings and clinical events rather than measuring tumor size alone. A participant who did not die or show disease progression was considered to have achieved progression-free survival under the registry definition.

In general, a fixed-time progression-free survival rate offers a way to describe the proportion of a study population meeting an event-free definition by a specified time. It can be easier to interpret as a group-level summary than a list of individual event times, but it does not convey the timing of every event or explain why a participant’s outcome occurred. The estimate is also meaningful only alongside its population definition and uncertainty.

The registry record gives the endpoint definition and timeframe but does not report the observed rate or its 95% confidence interval. The record therefore does not provide the numerical primary endpoint result needed to describe the rate’s magnitude or precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry records a percentage endpoint with a 95% confidence interval as its dispersion measure. However, it does not report the actual percentage or interval, and it does not describe the statistical method used to calculate them. The interpretation below therefore distinguishes general statistical principles from methods documented for this study.

What a percentage endpoint represents

In general, a percentage for a binary outcome summarizes the share of a defined group that meets a specified condition. Here, the condition was remaining alive without recorded disease progression up to 12 months following treatment initiation. The endpoint definition determines which events count against that status: a new lesion, symptomatic deterioration, progression of target or nontarget lesions, or death. A percentage cannot be interpreted without knowing both the event definition and the population used as its denominator.

The registry defines the primary population as participants with measurable disease at baseline who received study drugs, excluding those from one prematurely closed site when efficacy data were unavailable. The record does not state the size of that population or report the number meeting the endpoint. As a result, neither the numerator nor denominator for the primary percentage is available in the recorded results.

What a confidence interval conveys

In general, a confidence interval expresses statistical uncertainty in an estimate, conditional on the data and the method used to calculate the interval. It is not a guarantee that the true value lies within a particular interval, and it does not measure all sources of uncertainty. For example, an interval does not by itself account for limitations arising from the study design, the endpoint definition, missing outcome data or the applicability of the study population to other settings.

The endpoint specifies a 95% confidence interval, but no bounds are reported. The statistical procedure used to construct that interval is not reported in the registry record. It is therefore not possible to assess the precision of the rate or determine whether any particular interval assumptions were used.

Event-time outcomes and fixed-time rates

In general, a fixed-time rate and a time-to-event analysis answer related but distinct questions. A fixed-time rate focuses on the proportion meeting an event-free definition by a stated time. A time-to-event analysis uses the timing of events and can account for participants whose event status is not observed through the full follow-up period, depending on the method and its assumptions. The registry lists both a 12-month rate and other time-to-event outcomes, including median time to progression-free survival and median overall survival. It does not report the associated estimates or the methods used to analyze them.

Time-to-event methods require careful handling of censoring, which occurs when an event time is not observed within a participant’s available follow-up. In general, censoring methods rely on assumptions about how follow-up ends. The registry record does not describe censoring rules, follow-up completeness, or the assumptions used for any time-to-event analysis. Those details should not be inferred from the endpoint titles alone.

Study design and statistical comparison

The design is recorded as non-randomized and single-group, with no masking. In general, random allocation helps create groups that can be compared while reducing systematic differences in measured and unmeasured characteristics. This study has no randomized comparison group, so its design supports description of the treated group rather than a randomized estimate of a contrast between treatments. No comparative efficacy analysis is reported in the registry record.

The registry records 0 analyses. Statistical analysis methods, adjustments, model choices and any interim analyses are not reported in the registry record. A particular method cannot be inferred merely from the fact that an endpoint has a percentage unit or a confidence interval as its stated dispersion.

Planning assumptions and observed results

In general, a sample-size calculation is a planning exercise that depends on assumptions about the effect to detect, the significance level, allocation and statistical method. The planning illustration associated with the posted materials is described as using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect defined as a stated fraction of the observed effect. These are assumptions for a planning illustration; they are not documented as the trial’s original design justification. The study itself is a single-group, non-randomized trial, so the two-arm assumptions do not describe its recorded allocation.

A planning illustration is not an observed result and is not observed power. It cannot supply a missing endpoint estimate or establish the probability that the study detected an effect. The registry record does not report the original sample-size justification. It also does not report whether planned sample size or analysis decisions changed during the study.

Overall, general statistical concepts help clarify what the endpoint and confidence interval are intended to convey, but the record lacks the estimates and analysis details needed to assess the primary result. Any fuller methodological account would require information not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Oxaliplatin/Docetaxel/Bevacizumab")
n      <- c(70)
events <- c(46)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Oxaliplatin/Docetaxel/Bevacizumab  70  46  65.7  53.4  76.7  54.0  75.8  54.0  75.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and several additional outcomes concerning progression, response, recurrence, CA-125 and overall survival. When a study examines multiple outcomes, there can be more than one opportunity to observe a result that appears notable by chance. In general, multiplicity procedures can address this issue by controlling how statistical evidence is interpreted across multiple tests. The registry record does not report whether any multiplicity adjustment was planned or used, and no analysis results are recorded for these outcomes.

The record identifies the primary endpoint population as participants with measurable disease at baseline who received study drugs, excluding participants from one site that closed prematurely and for whom efficacy data were unavailable. This is the specific missing-efficacy-data issue documented in the population description. The number of participants affected is not reported. Detailed rules for handling missing outcomes, loss to follow-up, or incomplete assessments are not reported in the registry record.

The population is described as intent-to-treat, but it also includes the stated exception for the site with unavailable efficacy data. That wording should be read as the registry’s recorded population definition; it does not provide enough detail to reconstruct participant flow or determine how all other deviations and missing observations were handled. The enrollment figure alone does not establish the analyzed denominator.

The registry records 0 analyses. It does not report an analysis plan, multiplicity strategy, missing-data method, interim analyses or sensitivity analyses. These are not grounds for assuming that a specific approach was or was not used outside the registry record. They mean that those methods cannot be evaluated from the recorded information.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: nausea (5.3%), vomiting (5.3%), small intestinal obstruction (3.8%), pulmonary embolism (3.8%), febrile neutropenia (3.0%).

The adverse event record lists one group receiving oxaliplatin, docetaxel and bevacizumab. It reports 132 participants at risk for serious adverse events and 33 affected in that category. It also reports 132 at risk for other adverse events and 130 affected in that category. These are counts in the registry record; they are not efficacy outcomes and should not be used to infer the primary progression-free survival rate.

The record lists the following top serious adverse event terms with their reported percentages: nausea, 5.3%; vomiting, 5.3%; small intestinal obstruction, 3.8%; pulmonary embolism, 3.8%; febrile neutropenia, 3.0%; and abdominal pain, 2.3%. The registry record does not provide further detail about event severity grading, duration, recurrence, attribution to study drugs, or how the listed terms were selected as the top terms.

In general, adverse event counts describe events recorded under a study’s monitoring and reporting procedures. They do not, by themselves, establish that a treatment caused an event. The deaths value is not reported in the registry record. Accordingly, these figures should be read as the safety information recorded for this group, not as a complete characterization of risk or as a comparison with another treatment.

13. What the Result Does, and Does Not, Mean

The record establishes that a phase II, non-randomized, single-group study evaluated oxaliplatin, docetaxel and bevacizumab as first-line therapy in participants with specified ovarian, primary peritoneal or fallopian tube cancers. It also defines a 12-month progression-free survival endpoint and describes how progression was assessed. These details explain the clinical question and the outcome the trial was intended to measure.

The record does not report the primary endpoint estimate or its confidence interval. It therefore cannot establish the observed 12-month progression-free survival rate or how precisely that rate was estimated. The other listed efficacy outcomes likewise have no reported analyses in the registry record. No efficacy conclusion should be drawn from outcome names, enrollment, or adverse event figures.

The study’s design also limits what an outcome estimate could establish. A single treatment group can describe outcomes among participants in that group, but it does not provide a randomized comparison with another regimen. Without such a comparison, observed outcomes cannot be interpreted as a randomized treatment difference. The registry record also does not report a protocol justification for the sample size or detailed statistical analysis methods.

The safety counts and listed serious adverse event terms are useful descriptions of what the registry records for the treatment group. They do not establish causation, and the record does not provide a concurrent control group against which to compare them. Nor does the unavailable deaths value permit a conclusion about deaths from the safety record.

In general, evidence is most informative when the endpoint result, uncertainty, analysis population, missing-data handling and design are considered together. In this record, the endpoint and population definitions are available, but key results and methods are not. The defensible interpretation is consequently limited to describing the study’s design, stated aims, endpoint definitions and recorded safety counts. It does not support a claim that the combination is effective or ineffective, or that it is better or worse than another treatment.

14. Why This Trial Matters Statistically

This trial is statistically notable as a single-group evaluation of a combination regimen with a defined fixed-time progression-free survival endpoint. Its design makes clear why an endpoint definition and analysis population matter: the primary rate was intended for participants with measurable disease at baseline who received study drugs, with an exception for one site whose efficacy data were unavailable. A percentage cannot be interpreted without keeping that population in view.

The registry also illustrates the distinction between an outcome being specified and an outcome result being reported. The primary endpoint has a stated timeframe, clinical definition and confidence-interval measure, but the numerical rate and interval are not reported. The record lists other outcomes as well, yet records 0 analyses. Readers therefore need to distinguish the presence of an endpoint description from evidence about its observed value.

The single-group design is another central statistical feature. It allows a description of outcomes in the treated group, but it does not create a randomized, like-for-like control comparison. This matters when interpreting any eventual group-level estimate: the design alone cannot determine how the outcome would differ under another treatment. The study should not be read as a head-to-head trial.

Finally, the registry’s population exception and the absence of detailed missing-data and analysis methods highlight the importance of reporting participant flow and analytic decisions. These details affect how readers assess the denominator, uncertainty and scope of an outcome estimate. Here, they are not reported in enough detail to reconstruct the primary analysis. The statistical significance of the record is therefore in its clear endpoint and design description, alongside the limits imposed by unreported results and methods.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary endpoint result and its 95% confidence interval are not reported in the registry record. The number of participants in the primary analysis population is also not reported, so the recorded enrollment cannot be used as the endpoint denominator. The population definition excludes participants from one site that closed prematurely and for whom efficacy data were unavailable, but the number excluded and the handling of other missing observations are not described.

The design was non-randomized and single-group, with no masking. There is no concurrent randomized comparator to support a treatment contrast. The registry does not report detailed treatment administration, adherence, follow-up completeness, censoring rules, statistical models, analysis adjustments, multiplicity procedures, interim analyses or sensitivity analyses. These details are not reported in the registry record and should not be inferred.

The registry describes the study as a feasibility study and lists a broad population spanning FIGO stage IB through IV and several related cancer diagnoses. The record does not report subgroup outcome results or analyses that would clarify whether estimates differed across those population categories. It also does not report the original sample-size justification. The separate planning illustration uses two-arm assumptions, whereas the registered study is single-group; it should not be mistaken for the study’s documented design rationale or an observed result.

Safety information is limited to the recorded counts, listed serious event terms and percentages. Further details about severity grading, attribution, duration, recurrent events and the deaths value are not reported in the registry record. These limits prevent a fuller safety interpretation or a comparative safety assessment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary — NCT00296816.
• Registry record last updated 2012-08-23; status last verified 2011-08.
• Results first posted 2012-08-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT00296816 is a completed phase II study of oxaliplatin, docetaxel and bevacizumab as first-line therapy for participants with FIGO stage IB through IV ovarian, primary peritoneal or fallopian tube carcinoma. The study was non-randomized, single-group and unmasked, with an enrollment of 132. The primary endpoint was the 12-month progression-free survival rate in a specified measurable-disease population.

The registry record defines progression and the endpoint population, and lists adverse event counts for the combination group. It does not report the numerical primary endpoint result, its confidence interval, or analyses for the listed efficacy outcomes. The design does not include a randomized comparator, and detailed statistical and missing-data methods are not reported in the registry record.