This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers (NCT00177255), a na phase 2 study. The primary outcome is Overall Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00177255 |
| Phase | Phase 2 |
| Condition | Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pittsburgh |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with advanced gastric and gastro-esophageal adenocarcinomas. The registry lists the condition more broadly as Cancer, and does not report a more detailed primary-endpoint analysis population.
Intervention
The regimen combined docetaxel and capecitabine. The record describes docetaxel 30mg/m2 as a 30-minute infusion on days 1 and 8 of each 21-day cycle. It does not give a complete capecitabine dosing description. The record also mentions dexamethasone premedication, but that description is cut off.
Comparator
There was no listed comparator group. The study is classified as single-group, with allocation recorded as NA and masking recorded as none. Consequently, the registry record does not support a direct comparison of this regimen with another treatment or with a control group.
Primary question
The primary endpoint was overall survival, measured in months. The endpoint description defines survival time from the date a patient first received protocol treatment to the documented date of death. The planned summary was the median with a 95% confidence interval, over a timeframe listed as 2 years.
In statistical terms, the study was intended to investigate survival under the docetaxel–capecitabine regimen in the stated advanced cancer population. The registry record does not report the median overall survival, its confidence interval, or an analysis result for this endpoint. It therefore does not establish the observed survival experience in a way that can be evaluated from the record alone.
Overall response rate is listed as a secondary outcome, but no response-rate result is reported in the registry record. The information available also does not identify a separate untreated or active-comparator group. Any interpretation must therefore distinguish the study's stated question from the estimates and comparisons that the registry record actually documents.
3. Trial Design
This was a phase II study sponsored by the University of Pittsburgh. Its title describes docetaxel in combination with capecitabine in stomach and esophagus cancers; the official title specifies weekly docetaxel with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. The registry lists an enrollment of 40 and records the study status as terminated. The listed start date is 2005-04, and primary completion is recorded as 2008-12. The reason for termination is not reported in the registry record.
The design is classified as single-group. Allocation is listed as NA, and masking as none. The record describes one arm, Docetaxel + Capecitabine, rather than separate treatment and control arms. This design can describe outcomes among participants treated in the study, if results are reported, but it does not create a randomized like-for-like comparison. Differences from outcomes in another study or population would not be controlled by this design.
The intervention description states that docetaxel 30mg/m2 was to be administered as a 30-minute infusion on days 1 and 8, with each cycle consisting of 21 days. The record mentions dexamethasone premedication for patients receiving weekly docetaxel therapy, but the available description ends before the rationale is complete. The capecitabine schedule and dose are not reported in the registry record. These omissions prevent a complete reconstruction of the intended regimen from the record.
Overall survival was the primary outcome, with median survival and a 95% confidence interval specified. Overall response rate was listed as a secondary outcome. The record lists two outcome measures, but no analyses are listed. It does not report the statistical analysis plan, the analysis population, eligibility details, or the reason the study was terminated. These gaps limit assessment of how the design was implemented and how the planned outcomes were analyzed.
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 + Capecitabine |
|---|---|
| STARTED | 39 |
| COMPLETED | 39 |
| 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 | Docetaxel + Capecitabine |
|---|---|---|
| Participants analysed | 39 | |
| Age, Continuous | years | 61 (21 to 84) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures the time from a defined starting point until death. In this study, the endpoint description sets the starting point as the date a patient first received protocol treatment and the event date as the documented date of death. The unit is months, and the registry names the median as the summary measure. The timeframe is listed as 2 years.
The median is a way to describe the middle of an observed time-to-event distribution. It does not describe every participant's experience, and it is different from an average. A 95% confidence interval expresses statistical uncertainty around an estimated median; it indicates a range of values compatible with the analysis under its assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates less precision.
Overall survival is a time-to-event endpoint because the outcome is the time until a specified event, rather than simply whether the event occurred at one fixed assessment. Such endpoints can retain information about when events occurred. Their interpretation depends on the recorded event times and how participants without a recorded event by the analysis time are handled. Those details are not reported in the registry record.
The registry record gives the endpoint definition and intended summary but no median estimate or confidence interval. It also does not provide a reported survival analysis or explain how the listed 2 years relates to follow-up or censoring. As a result, the endpoint's intended meaning can be described, but its observed magnitude and precision cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the basic design and endpoint but does not report the primary outcome result. Overall survival was to be summarized as a median in months with a 95% confidence interval. Neither the median nor its interval appears in the record. There is therefore no reported numerical survival estimate to interpret, and no basis in this record for describing the precision of such an estimate.
The study was single-group and had no listed comparator. Its design does not permit a randomized comparison of docetaxel plus capecitabine against another regimen or control. Even if an outcome estimate were available, an outcome observed in a single group would describe that study group; it would not by itself identify what would have happened to comparable participants under a different treatment. This distinction is central to interpreting phase II single-group evidence.
The record lists overall response rate as a secondary outcome, but does not report a result for it. The registry lists two outcome measures and 0 analyses. This means the record does not contain the outcome analyses needed to judge response or survival. The status is terminated, but the reason for termination and the relationship between termination and any analysis are not reported in the registry record. Termination alone does not establish that results were unfavorable, that the study stopped early, or why it ended.
Safety information is present for the Docetaxel + Capecitabine group. The record lists 39 at risk for serious adverse events and 20 affected; for other adverse events it lists 39 at risk and 37 affected. It also provides percentages for several serious adverse-event categories. These are descriptive figures, not comparisons with another group. The registry record does not provide enough detail to assess event timing, duration, severity grading, relatedness to treatment, or the rules used to classify events.
The registry's enrollment value is 40, while the adverse-event denominators are listed as 39. These entries refer to different record fields; the reason for the difference is not reported in the registry record. They should not be reconciled by assuming an analysis population, a withdrawal, or a particular safety-data convention.
Overall, the posted information supports a description of the intended regimen, design, endpoint, and selected safety counts. It does not provide the clinical outcome estimates required to characterize the observed overall-survival or response results. The absence of those estimates is a limitation of what can be concluded from the registry record, rather than evidence about the size or direction of an effect.
9. Statistical Methods Explained
What does the single-group design permit?
General statistical explanation: a single-group study observes outcomes among people receiving the study regimen. It can describe the outcomes recorded in that group, but it has no concurrent randomized group to estimate what would have happened under a different treatment. A comparison with an external group can be affected by differences in patient characteristics, care, follow-up, and outcome measurement. Those influences cannot be separated from treatment differences by randomization within this study.
In this record, the design is identified as single-group, allocation is NA, and masking is none. The listed arm is Docetaxel + Capecitabine. Thus, the study design does not provide a like-for-like randomized control comparison. The registry record does not report an adjusted comparative analysis or a sponsor-reported hazard ratio. It also lists 0 analyses. No treatment-effect estimate or comparative inference should be reconstructed from the design description alone.
How should a median survival estimate be understood?
General statistical explanation: a median time-to-event estimate describes the point at which the estimated survival distribution reaches its midpoint. It is a summary of the distribution of event times, not a statement that every participant experienced the same duration. The confidence interval communicates uncertainty in that estimate. Neither statistic can be interpreted without the underlying analysis and its assumptions.
The primary endpoint is defined as the interval from first protocol treatment to documented death, with months as the unit, a median summary, and a 95% confidence interval. The timeframe is listed as 2 years. However, no median, interval limits, event count, or survival-curve estimate is reported in the registry record. The reader therefore cannot assess the result's magnitude, precision, or shape from these endpoint specifications.
General statistical explanation: time-to-event analysis often accounts for participants whose event has not been observed by the end of available follow-up. Such observations are commonly treated as censored at a specified time, rather than treated as if the event occurred at that time. Interpretation depends on censoring definitions and assumptions, follow-up completeness, and the timing of events. The registry record does not report these details, so the analysis approach cannot be reconstructed.
What do the planning assumptions mean?
The record describes sample-size assumptions as a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the described planning quantity is a total number of events; for other outcomes, it is participants per arm. These are planning conventions, not results from this single-group trial.
General statistical explanation: a sample-size illustration estimates the information or enrollment that might be needed under specified assumptions. It is conditional on those assumptions and on the effect size used. An illustration based on an observed effect is not an independent confirmation of that effect, and a planning calculation is not observed power. The record does not provide numerical planning results or identify a trial-specific design justification. It also does not say that the trial itself used equal allocation between two arms; that assumption is inconsistent with the listed single-group design as a description of the enrolled trial and should be read only as part of the planning illustration.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when the observed variability in data is greater than a statistical model assumes. If a model fails to account for that extra variability, standard errors may be too small and confidence intervals may be too narrow. This issue can arise for some outcome types, but the registry record does not report an analysis model for response or other outcomes. It is therefore not possible to determine whether over-dispersion was relevant or how it was handled in this study.
What does the analysis record tell us?
The registry lists 0 analyses and provides no reported primary-endpoint estimate. It does not report the analysis population, censoring rules, missing-data procedures, covariate adjustments, interim analyses, or a detailed statistical plan. These omissions make it impossible to verify whether the recorded endpoint specifications were followed or to assess the robustness of an analysis. They also prevent an independent recalculation from posted summary statistics. The appropriate statistical reading is limited to the design and data definitions the record actually reports.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names overall survival as the primary outcome and overall response rate as a secondary outcome. It lists two outcome measures and 0 analyses, but does not report results for either named outcome. The statistical plan for handling multiple outcomes is not reported in the registry record. In particular, the record does not state whether any adjustment for multiple testing was planned or how a primary result would be distinguished from exploratory findings.
General statistical explanation: when multiple outcomes or repeated statistical tests are examined, the chance of at least one apparently notable result can increase if each test is interpreted without regard to the others. Prespecified outcome hierarchies or multiplicity adjustments can address this issue, but the appropriate approach depends on the study's aims and analysis plan. No such approach can be attributed to this trial from the record.
Missing-data procedures are also not reported in the registry record. The record does not say how missing endpoint dates, incomplete follow-up, or participants without a recorded death by the end of observation were handled. For time-to-event outcomes, censoring is not interchangeable with ordinary missing outcome data; its definition and assumptions affect interpretation. The record does not provide those definitions or describe follow-up completeness.
The analysis population is not reported in the registry record. It is therefore unclear which participants were included in any endpoint analysis, and the record provides no account of exclusions or deviations from the intended regimen. The enrollment entry of 40 should not be treated as proof that all listed participants contributed to every endpoint analysis. Nor should the adverse-event denominators be taken to define the primary-outcome population.
The reason for termination, any interim analyses, and the prespecified statistical plan are not reported in the registry record. Without these details, readers cannot assess whether outcome reporting reflects a prespecified analysis or determine how missing information and multiplicity may have affected conclusions.
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 + Capecitabine | 20 | 39 | 51.3% |
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 + Capecitabine | 37 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel + Capecitabine |
|---|---|---|
| Constitutional Symptoms-Other | General disorders | 6 of 39 |
| Gastrointestinal-Other | Gastrointestinal disorders | 4 of 39 |
| Pulmonary-Other | Respiratory, thoracic and mediastinal disorders | 4 of 39 |
| Cardiovascular/General-Other | Cardiac disorders | 2 of 39 |
| Blood/Bone Marrow-Other | Blood and lymphatic system disorders | 1 of 39 |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | 1 of 39 |
| Ventricular arrhythmia | Cardiac disorders | 1 of 39 |
| Hypotension | Vascular disorders | 1 of 39 |
| Thrombosis/Embolism | Vascular disorders | 1 of 39 |
| Anorexia | Metabolism and nutrition disorders | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel + Capecitabine |
|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | 26 of 39 |
| Nausea | Gastrointestinal disorders | 19 of 39 |
| Mucositis/stomatitis (clinical exam), Oral cavity | Gastrointestinal disorders | 18 of 39 |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | 17 of 39 |
| Diarrhea | Gastrointestinal disorders | 16 of 39 |
| Anorexia | Metabolism and nutrition disorders | 14 of 39 |
| Hemoglobin | Blood and lymphatic system disorders | 14 of 39 |
| Neuropathy: sensory | Nervous system disorders | 12 of 39 |
| Constipation | Gastrointestinal disorders | 10 of 39 |
| Neurology - Other | Nervous system disorders | 10 of 39 |
Serious events with the highest arm-level rate: constitutional symptoms-other (15.4%), gastrointestinal-other (10.3%), pulmonary-other (10.3%), cardiovascular/general-other (5.1%), blood/bone marrow-other (2.6%).
The registry lists safety information for the Docetaxel + Capecitabine group. For serious adverse events, 39 are listed as at risk and 20 as affected. For other adverse events, 39 are listed as at risk and 37 as affected. These counts describe the entries in the registry; they do not establish how events were defined, how often events recurred, or whether they were attributed to treatment.
The listed serious adverse-event categories and percentages are Constitutional Symptoms-Other, 15.4%; Gastrointestinal-Other, 10.3%; Pulmonary-Other, 10.3%; Cardiovascular/General-Other, 5.1%; Blood/Bone Marrow-Other, 2.6%; and Neutrophils/granulocytes (ANC/AGC), 2.6%. These category percentages should be read as registry-reported descriptions, not as comparisons between treatments. The record does not provide corresponding control-group figures.
The registry does not report a death count for this safety entry. The definitions of the categories, event collection period, severity grading, relatedness assessment, and handling of repeated events are not reported in the registry record. The safety figures therefore offer limited descriptive information and cannot by themselves establish causation, comparative risk, or the completeness of safety reporting.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, single-group study investigated docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. It specifies overall survival as the primary endpoint, defines the time origin and event, and names a median with a 95% confidence interval as the intended summary. It also lists overall response rate as a secondary outcome and gives selected adverse-event counts and categories.
Those design details do not amount to a report of clinical outcomes. The registry record does not give the overall-survival median, its confidence interval, or an overall response-rate result. It lists 0 analyses. Consequently, the posted information cannot establish the magnitude or precision of observed survival or response, nor can it support a treatment-effect comparison.
The single-group design has no listed comparator. General statistical explanation: outcomes within one treated group may reflect the regimen, the participants' underlying illness, other care, and other influences. Without a randomized comparison, those contributions cannot be cleanly separated. A result from a single group, even if reported, would describe that group and would not establish what would have happened to comparable participants under another treatment.
The safety entries are also descriptive. Counts and category percentages do not show whether an event was caused by treatment, and no control-group safety data are listed. The record does not describe event timing or relatedness. It also does not provide the reason for termination, analysis population, or missing-data procedures.
The status of terminated should not be interpreted as evidence of benefit, lack of benefit, harm, or a particular reason for stopping. The record reports no reason. Likewise, the enrollment entry and adverse-event denominators do not reveal why their values differ. The most defensible conclusion is that the registry record documents a study design and selected safety information but lacks the outcome analyses needed to characterize efficacy or comparative safety.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a study's question, design, and reported results must be kept distinct. The primary endpoint is clearly named and defined, but its estimate and confidence interval are absent. Knowing that the intended summary was a median overall survival does not reveal the observed median or how precisely it was estimated.
The single-group design is equally important to interpretation. It can support a description of outcomes among participants in the regimen group if those outcomes are reported, but it does not provide a randomized control comparison. A claim about comparative effects requires an appropriate comparator and analysis; neither is documented. This limits what the design could establish even apart from the missing result.
The record also illustrates how registry status and outcome reporting should be interpreted cautiously. The study is marked terminated, but the reason is not reported. Termination is not itself an outcome and does not explain why the primary endpoint result is absent. The record lists 0 analyses, so it does not permit assessment of the analysis methods, endpoint handling, or uncertainty.
Finally, the safety entries show the difference between descriptive counts and a full safety assessment. The registry provides serious and other adverse-event counts, along with selected serious-event categories, but no comparison group or detail on timing, severity, attribution, and collection. The figures can be reported as recorded, but they do not answer broader causal or comparative questions.
The statistical value of careful reading is therefore not to fill gaps with assumptions, but to identify which claims the available record can support. Here, design and endpoint definitions are available; the primary and secondary outcome results are not.
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 primary limitation is that the registry record does not report an overall-survival estimate or its 95% confidence interval. It also does not report the secondary overall response rate. Although two outcome measures are listed, 0 analyses are recorded. This prevents assessment of the study's primary clinical outcome, its statistical precision, or the relation between the intended and reported analyses.
The study is classified as single-group, with no comparator. Thus, the record does not provide a randomized treatment comparison. Masking is listed as none, and the record does not describe independent outcome adjudication. It does not report the detailed eligibility criteria, analysis population, or whether participants were analyzed according to treatment received.
The treatment description is incomplete. It gives a docetaxel schedule and mentions dexamethasone premedication, but the premedication description is cut off and a complete capecitabine schedule is not reported. The reason for the terminated status is not reported. The record also does not provide the statistical analysis plan, interim-analysis information, or sample-size justification for the trial itself.
For overall survival, follow-up completeness, event counts, censoring rules, and missing-data procedures are not reported. The timeframe is listed as 2 years, but the record does not clarify how that timeframe relates to individual follow-up or analysis. Without these details, even a reported estimate would be difficult to evaluate fully.
Safety information is limited to the listed at-risk and affected counts and selected serious-event categories. Event definitions, collection duration, relatedness, severity grading, and repeated-event handling are not reported in the registry record. A death count is also not reported. These limitations restrict interpretation of both the outcome record and the safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers — NCT00177255.
- Registry record last updated 2016-02-08; status last verified 2016-01.
- Results first posted 2016-02-08.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00177255 is a University of Pittsburgh phase II study of docetaxel with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. The registry classifies the design as single-group, with allocation recorded as NA and masking as none. Enrollment is listed as 40; status is terminated. The listed start date is 2005-04 and primary completion is 2008-12.
Overall survival was the primary endpoint, defined from first protocol treatment to documented death and intended to be summarized by a median in months with a 95% confidence interval. Overall response rate was listed as a secondary outcome. The registry record does not report results for either outcome and lists 0 analyses.
For the Docetaxel + Capecitabine group, the record lists 39 at risk and 20 affected by serious adverse events, and 39 at risk and 37 affected by other adverse events. The reason for termination, analysis population, and detailed statistical methods are not reported in the registry record.