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, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer (NCT00394433), a na phase 2 study. The primary outcome is 10-month Progression-Free Survival Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00394433 |
| Phase | Phase 2 |
| Condition | Esophageal Cancer, Stomach Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dana-Farber Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic esophageal or gastric cancer were eligible for this trial. The primary endpoint’s analysis population is described as all enrolled patients. The registry record reports 38 enrolled.
Intervention
The study evaluated the combination of docetaxel, cisplatin, irinotecan and bevacizumab, referred to as TPCA. The regimen description specifies bevacizumab on day 1 of each 3-week cycle and the three chemotherapy agents on days 1 and 8.
Comparator
There was no separate comparison group. The trial is recorded as single-group, with allocation listed as not applicable and masking as none. Its results therefore cannot provide a like-for-like randomized comparison with another treatment.
Primary question
The primary endpoint asks what proportion of patients are estimated to be alive and progression-free at 10 months from study entry. The registry describes estimating this probability with Kaplan-Meier methods. The estimated rate and its 95% confidence interval are not reported in the registry record.
The research question was whether the combination could be evaluated for tumor response and disease control in metastatic esophageal or gastric cancer. Best response, overall survival and progression-free survival are also listed as secondary outcomes. Because the trial has one group and no concurrent control, the primary result would describe outcomes among patients treated in this study; it would not, by itself, estimate how those outcomes compare with another treatment or what would have happened without TPCA.
3. Trial Design
This is a phase II trial registered as NCT00394433, sponsored by Dana-Farber Cancer Institute. The registry identifies it as completed, with a single-group model, allocation listed as not applicable, and no masking. The record reports 38 enrolled. The listed start and primary completion dates are 2006-09 and 2008-11.
The treatment group is named Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA). The regimen description states that bevacizumab was given intravenously on day 1 every 3 weeks while patients remained on study. Docetaxel, cisplatin and irinotecan were described as intravenous treatments on days 1 and 8 of each 3-week cycle. Treatment was described as continuing until disease progression or unacceptable toxicity. The registry record does not report further detail on treatment exposure or dose changes.
Disease was evaluated radiologically at baseline and every 2 cycles on treatment, according to the primary endpoint timeframe description. The primary endpoint concerns progression-free survival at 10 months. Best response, overall survival and progression-free survival are listed as secondary outcomes. The registry record does not report a concurrent control group or a randomized comparison, so this design is descriptive of outcomes in the treated group rather than a direct comparison of treatment strategies.
The enrollment figure describes the trial’s reported enrollment; it does not establish how many participants contributed to each outcome analysis. The registry identifies all enrolled patients as the primary endpoint analysis dataset, but does not report the number with endpoint data or the handling of missing follow-up.
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, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
|---|---|
| STARTED | 38 |
| Evaluable and Treated | 35 |
| COMPLETED | 35 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
|---|---|
| Adverse Event | 2 |
| Alternative Therapy | 1 |
Analysis population for the primary outcome, as defined in the registry: The analysis dataset is comprised of all enrolled patients.
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.
Population: The analysis dataset is comprised of all enrolled patients.
| Characteristic | Unit | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
|---|---|---|
| Participants analysed | 38 | |
| Age, Continuous | years | 58 (31 to 76) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 32 |
| Race/Ethnicity, Customized: White | Participants | 33 |
| Race/Ethnicity, Customized: Black or African American | Participants | 2 |
| Race/Ethnicity, Customized: Hispanic | Participants | 3 |
| Region of Enrollment: United States | Participants | 38 |
| Primary Site of Disease: Esophageal | Participants | 13 |
| Primary Site of Disease: Gastroesophageal junction | Participants | 9 |
| Primary Site of Disease: Gastric | Participants | 16 |
6. Primary Endpoint
The registry lists the primary outcome as 10-month Progression-Free Survival Rate, measured over Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | probability (%) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the 10-month progression-free survival rate. It is defined as the probability that a patient is alive and has not experienced disease progression at 10 months from study entry. It is a time-to-event outcome: both the timing of progression or death and the length of observed follow-up are relevant, rather than only whether progression was ever recorded.
The registry states that the rate was estimated using Kaplan-Meier methods. In general, Kaplan-Meier estimation uses the observed event times and follow-up information to estimate the probability of remaining event-free over time. A confidence interval communicates uncertainty around that estimate; the registry identifies a 95% confidence interval as the dispersion measure for this endpoint. Neither the estimated 10-month rate nor the confidence interval limits are reported in the registry record.
Progression was defined using RECIST 1.0 criteria. For target lesions, the record describes progressive disease as at least a 20% increase in the sum of longest diameters, using the smallest recorded sum since treatment started as the reference, or the appearance of one or more new lesions. For non-target lesions, progression includes new lesions or unequivocal progression of non-target lesions.
A fixed-time progression-free survival estimate is used to express disease control at a clinically interpretable follow-up point. It combines being alive and free of progression at that time; it is not simply a response rate or a measure of tumor shrinkage alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant time-to-event endpoint and describes how it was intended to be estimated, but it does not report the endpoint result. No 10-month progression-free survival estimate or 95% confidence interval is available in the registry record. Consequently, the posted information does not establish the observed probability of being alive and progression-free at 10 months, nor how precisely that probability was estimated.
This absence matters for interpretation. A point estimate would describe the outcome observed in the study group, while its confidence interval would indicate the range of values compatible with the data under the statistical method. Without either, readers cannot assess the magnitude of the endpoint, its precision, or whether the estimate is compatible with a wide range of possible outcomes. The record’s description of Kaplan-Meier estimation is a methods statement, not a numerical result.
The trial is recorded as single-group, with no masking and no allocation to a comparison arm. Therefore, even if a numerical outcome estimate were available, it would describe outcomes in this study group rather than establish a treatment effect relative to a concurrent control. Differences from outcomes in other populations or studies could reflect differences in participants, follow-up, assessment, or other features; the registry record does not provide a randomized basis for separating those possibilities.
The secondary outcomes listed are best response, overall survival and progression-free survival. Their names alone do not convey observed results. Numerical estimates, uncertainty intervals and analysis details for these outcomes are not reported in the registry record. The record also does not report analysis-level comparisons or p-values. No conclusion about the size, precision or statistical significance of these outcomes can be drawn from their listing.
The enrollment figure is 38, and the primary endpoint population is described as all enrolled patients. That population description does not show how many had complete follow-up to 10 months or how the analysis handled participants whose follow-up ended earlier. Those details affect how a time-to-event estimate is interpreted and are not reported in the registry record.
In statistical terms, the available information supports describing the design and the intended endpoint, but not evaluating the observed clinical outcome. It also does not support a claim that the regimen improved outcomes or failed to do so. The endpoint estimate, its uncertainty, and a suitable comparison would be needed for those assessments; the registry record does not report them.
9. Statistical Methods Explained
The registry describes a single-group phase II study and a primary time-to-event endpoint. These design and endpoint features determine what statistical interpretation is possible. The endpoint is the estimated probability of being alive and progression-free at 10 months after study entry, with Kaplan-Meier methods and a 95% confidence interval specified.
What does Kaplan-Meier estimation do?
In general, Kaplan-Meier estimation uses the times at which events occur together with each participant’s observed follow-up. It estimates the probability of remaining free of the event over time, updating that estimate as events are observed. Participants whose event status is not observed through the entire period can contribute information up to the time their follow-up ends. This general description does not establish how follow-up ending early was handled in this particular trial; that detail is not reported in the registry record.
For this endpoint, the event-free state requires both being alive and having no progression. The registry defines progression using RECIST 1.0 criteria, including at least a 20% increase in the sum of longest diameters of target lesions from the stated reference, or the appearance of new lesions. The record also describes criteria for progression of non-target lesions. A consistent event definition is important because the time-to-event estimate depends on when progression is classified as occurring.
What does the confidence interval convey?
In general, a confidence interval expresses statistical uncertainty around an estimated quantity. A narrower interval indicates greater precision under the assumptions of the method; a wider interval indicates less precision. It does not remove design limitations or account automatically for every possible source of bias. The registry identifies a 95% confidence interval for the primary endpoint, but its estimate and interval limits are not reported in the registry record. Precision therefore cannot be evaluated from the posted outcome information.
What does the single-group design allow?
The study has one treatment group and no randomized control group. The primary estimate, if reported, would characterize progression-free survival among the study group under the recorded endpoint definition. A single-group estimate does not directly quantify a treatment difference. In general, a concurrent randomized comparison helps distinguish differences associated with treatment assignment from differences due to participant characteristics, care, or other influences. That type of comparison is not part of this recorded design.
Allocation is listed as not applicable and masking as none. These entries describe the recorded design; they do not provide further information about outcome assessment procedures. The registry record does not report details of any independent or blinded endpoint review.
How should planning illustrations be understood?
Sample-size calculations are planning tools, not trial outcomes. The registry’s planning assumptions describe illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event planning, the assumptions describe the total number of events, while other planning settings describe participants per arm for 80% or 90% power. Such illustrations are not observed power and do not change the actual design of this single-group trial.
Because the trial has no two-arm randomized comparison, an equal-allocation two-arm planning scenario is not a description of the trial’s enrollment structure. In addition, the primary endpoint estimate needed to understand a planning illustration based on the observed effect is not reported in the registry record. The record does not report the trial’s own sample-size justification, so the planning assumptions should not be treated as the protocol’s design rationale.
What analysis details are unavailable?
The primary analysis population is described as all enrolled patients. The registry record does not report details of censoring rules, missing-data handling, assessment of model assumptions, sensitivity analyses, or subgroup analyses. It also does not report a statistical analysis plan or an interim-analysis plan. These omissions do not establish that such procedures were or were not conducted; they mean that they are not reported in the registry record.
Finally, a method description is not a result. The presence of an endpoint definition, a Kaplan-Meier method and a confidence-interval specification does not provide the estimated probability or its precision. With no numerical primary endpoint result reported, readers cannot assess how the observed follow-up translated into the 10-month estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry names one primary endpoint, 10-month progression-free survival, and lists best response, overall survival and progression-free survival as secondary outcomes. Considering several outcomes can raise multiplicity concerns: when multiple statistical claims are tested, the chance of at least one apparently notable finding can increase. This is a general statistical issue, not evidence that any particular result in this trial is false or positive.
The registry record does not report a multiplicity adjustment, a hierarchy for interpreting the secondary outcomes, or a statistical analysis plan specifying how multiple outcomes were to be handled. It also does not report numerical outcome results or analysis-level comparisons. The intended handling of multiplicity is therefore not reported in the registry record.
The primary endpoint population is described as all enrolled patients. The registry record does not report the number contributing usable follow-up at the 10-month assessment, the amount or pattern of missing outcome information, or the methods used for missing data. For a time-to-event endpoint, follow-up ending before progression or death may be handled through censoring in general statistical practice, but the registry does not describe the actual censoring rules used in this analysis.
The record does not report whether sensitivity analyses examined alternative assumptions about missing follow-up or endpoint assessment. It also does not provide details of an analysis population for the secondary outcomes. These limitations prevent assessment of how robust the outcome analyses were to missing information or analytical choices.
Absence of these details in the registry record should not be taken as proof that a method was not used. It means readers cannot verify the method from the recorded information. The reported all-enrolled analysis population is the only explicit population description for the primary endpoint.
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 |
|---|---|---|---|
| Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | 30 | 38 | 78.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | 37 of 38 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
|---|---|---|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 16 of 38 |
| Lymphopenia | Investigations | 12 of 38 |
| Neutrophils | Investigations | 12 of 38 |
| Leukocytes | Investigations | 9 of 38 |
| Fatigue | General disorders | 7 of 38 |
| Febrile neutropenia | Blood and lymphatic system disorders | 6 of 38 |
| Anorexia | Metabolism and nutrition disorders | 6 of 38 |
| Hypokalemia | Metabolism and nutrition disorders | 6 of 38 |
| Thrombosis/thrombus/embolism | Vascular disorders | 6 of 38 |
| Dehydration | Metabolism and nutrition disorders | 5 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
|---|---|---|
| Nausea | Gastrointestinal disorders | 30 of 38 |
| Hemoglobin | Blood and lymphatic system disorders | 28 of 38 |
| Fatigue | General disorders | 28 of 38 |
| Vomiting | Gastrointestinal disorders | 24 of 38 |
| Constipation | Gastrointestinal disorders | 22 of 38 |
| Leukocytes | Investigations | 20 of 38 |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | 19 of 38 |
| Alopecia | Skin and subcutaneous tissue disorders | 19 of 38 |
| Abdomen, pain | Gastrointestinal disorders | 18 of 38 |
| Anorexia | Metabolism and nutrition disorders | 18 of 38 |
Serious events with the highest arm-level rate: diarrhea w/o prior colostomy (42.1%), lymphopenia (31.6%), neutrophils (31.6%), leukocytes (23.7%), fatigue (18.4%).
The registry lists serious adverse event reporting for the TPCA group with 38 at risk and 30 affected. For other adverse events, it lists 38 at risk and 37 affected. These are recorded counts for the group; they are not comparative estimates because the trial has no control group. The registry’s death entry is not reported in the registry record.
The serious adverse event terms listed with their reported percentages are diarrhea w/o prior colostomy, 42.1%; lymphopenia, 31.6%; neutrophils, 31.6%; leukocytes, 23.7%; fatigue, 18.4%; and febrile neutropenia, 15.8%. These figures describe the registry’s listed terms. They should not be interpreted as treatment-attributable risks or as evidence about how the regimen compares with another treatment.
Adverse-event summaries depend on definitions, observation periods and reporting practices. The registry record does not provide further details about event severity grading, duration, relatedness assessment, or whether the listed terms can overlap within participants. The counts and percentages alone therefore do not describe the full clinical context or establish causation.
12. What the Result Does, and Does Not, Mean
The record describes a phase II evaluation of docetaxel, cisplatin, irinotecan and bevacizumab in metastatic esophageal and gastric cancer. It identifies 10-month progression-free survival as the primary endpoint and specifies Kaplan-Meier estimation with a 95% confidence interval. However, the numerical endpoint result and its interval are not reported in the registry record. The available outcome information therefore does not show the observed 10-month progression-free survival rate or its precision.
The study’s single-group design also limits what an outcome estimate could establish. A rate observed in the TPCA group would describe those participants’ outcomes under the study’s follow-up and endpoint definitions. Without a concurrent randomized comparator, it would not by itself show that the regimen caused better or worse outcomes than another treatment or than no treatment. Comparisons with results from other studies would not resolve this limitation automatically.
The record lists best response, overall survival and progression-free survival as secondary outcomes, but their numerical results are not reported in the registry record. The listed serious and other adverse event counts and serious-event terms describe safety reporting in the study group; they do not establish comparative risks or causation.
Thus, the registry record supports an account of the trial’s design, treatment, endpoint definition and selected safety reporting. It does not support a conclusion that the regimen worked or did not work, nor does it allow a judgment about the size or precision of the primary outcome. Those questions require outcome estimates and, for comparative treatment effects, an appropriate comparison design.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly named endpoint and a numerical result are both necessary for statistical interpretation. The registry defines a time-specific progression-free survival outcome and identifies Kaplan-Meier estimation and a 95% confidence interval. Those details clarify what the endpoint is intended to measure, but they cannot substitute for the estimated rate and its uncertainty, which are not reported in the registry record.
It also demonstrates the distinction between describing outcomes and estimating a treatment effect. A single-group study can characterize outcomes among participants receiving a regimen, but it does not create a randomized contrast against another treatment. This distinction matters when readers encounter an outcome rate: an observed rate is not automatically evidence that treatment assignment caused that outcome.
The planning assumptions offer another statistical lesson. Sample-size illustrations are conditional on assumptions and are used for planning; they are not a measure of the trial’s observed success or failure. Here, the stated planning framework includes equal allocation between two arms, whereas the registered trial is single-group. The planning assumptions should therefore be kept separate from the actual study design and should not be read as a description of trial allocation.
Finally, safety counts and percentages need context. Without comparative data and further reporting details, they describe what the registry records for this group rather than establishing how risks differ across treatments. Careful separation of design, estimation, uncertainty and comparison prevents claims from exceeding what the registry record can support.
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 trial-specific limitation is its single-group design. There is no randomized control arm, so the study cannot provide a direct like-for-like estimate of how the TPCA regimen compares with another treatment. Allocation is listed as not applicable and masking as none. The registry record does not report details of any independent or blinded review of disease progression.
The primary endpoint is defined and its planned estimation method is named, but the estimated 10-month progression-free survival rate and 95% confidence interval are not reported in the registry record. Without those results, the endpoint’s magnitude and precision cannot be assessed. Numerical results for the listed secondary outcomes are also not reported in the registry record.
The primary analysis population is described as all enrolled patients, but the registry record does not report how many had adequate follow-up, how incomplete follow-up was handled, or the censoring rules. It does not report missing-data methods, sensitivity analyses, or further statistical analysis details. These gaps limit assessment of the robustness of any time-to-event analysis.
The treatment description gives the regimen and states that treatment continued until progression or unacceptable toxicity, but the registry record does not report additional detail on treatment exposure or dose changes. The planning assumptions use an equal-allocation two-arm framework, which is distinct from the recorded single-group design; the record does not report the trial’s own sample-size justification. Together, these limitations restrict both clinical interpretation and independent statistical appraisal.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer — NCT00394433.
- Registry record last updated 2017-08-01; status last verified 2017-07.
- Results first posted 2017-01-16.
- 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
NCT00394433 is a completed phase II, single-group trial sponsored by Dana-Farber Cancer Institute. It enrolled 38 patients with metastatic esophageal or gastric cancer and evaluated docetaxel, cisplatin, irinotecan and bevacizumab. The registry lists 10-month progression-free survival as the primary endpoint, estimated with Kaplan-Meier methods and a 95% confidence interval. Best response, overall survival and progression-free survival are listed as secondary outcomes.
The primary endpoint estimate and confidence interval are not reported in the registry record. The record also does not report numerical results for the secondary outcomes, or details of missing-data handling and censoring. Serious adverse event reporting lists 30 affected among 38 at risk, and other adverse event reporting lists 37 affected among 38 at risk. With no randomized comparator, the study describes a treatment group rather than a comparative treatment effect.