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 Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery (NCT00448682), a na phase 2 study. The primary outcome is Number of Patients Achieving Clinical Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00448682 |
| Phase | Phase 2 |
| Condition | Gastric Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Miami |
| Results posted | Yes |
2. Clinical Question
The study concerned first-line treatment for people with stage IV gastric cancer that could not be removed by surgery. The official title describes the disease as metastatic gastric adenocarcinoma. The registry record does not report additional eligibility details or a more specific description of the population included in the analysis.
Population
Patients with metastatic gastric adenocarcinoma, described in the study title as stage IV gastric cancer that could not be removed by surgery. The record does not report a primary analysis population or analyzed participant characteristics.
Intervention
A combination of floxuridine (FUdR), leucovorin, oxaliplatin, and docetaxel (Taxotere). The record describes outpatient chemotherapy on days 1, 8, and 15 each week in a schedule of 3 out of 4 weeks, with some administration details for days 1 and 15.
Comparator
There was no separate comparator group. The study is recorded as a single-group phase II trial, with allocation listed as NA and no masking. It therefore does not provide a randomized comparison with another treatment or a control group.
Primary question
The primary endpoint was the number of patients achieving complete response or partial response according to RECIST Criteria version 1.0, with a timeframe of 1 year. The registry says the study data had not been analyzed, so it does not report the response result.
In statistical terms, the intended question was whether clinical responses were observed among patients receiving the combination. Without reported response counts or an analyzed population, the record cannot establish the observed response frequency or its precision. It also cannot show how outcomes compare with another regimen or with outcomes under a control condition.
3. Trial Design
This was a phase II, single-group study sponsored by the University of Miami. The registry lists enrollment as 25, allocation as NA, and masking as none. The study status is terminated. Its recorded start is 2005-06, and primary completion is recorded as 2009-12. The reason for termination is not reported in the registry record.
The investigational regimen combined docetaxel, floxuridine, leucovorin, and oxaliplatin. The arm description says chemotherapy was administered on an outpatient basis, weekly, 3 out of 4 weeks, on days 1, 8, and 15. It specifies oxaliplatin at 85 mg/m2 and docetaxel at 25 mg/m2 on days 1 and 15, followed by FUdR/leucovorin. The remaining dose description is incomplete in the registry record, so a complete schedule cannot be reconstructed from it.
Because there was no separate control arm and no random allocation, the study was not designed as a like-for-like treatment comparison. Its single-group structure can describe outcomes among participants who received the regimen if those outcomes are analyzed and reported. It cannot by itself separate a treatment-associated outcome from other influences on response or survival.
The registry identifies overall survival and the number of participants experiencing adverse events as secondary outcomes. It lists 3 outcome measures and 0 analyses. The primary response outcome is described as not analyzed. The record does not report the protocol’s statistical analysis plan, any interim analyses, or a sample-size justification. The enrollment value does not establish how many participants were treated, assessed, or included in any analysis.
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 | FUdR + Leucovorin + Oxaliplatin + Docetaxel |
|---|---|
| STARTED | 25 |
| COMPLETED | 25 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study data has not been analyzed.
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 | FUdR + Leucovorin + Oxaliplatin + Docetaxel |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | years | 62 (39 to 85) |
| Gender: Female | Participants | 7 |
| Gender: Male | Participants | 18 |
| Region of Enrollment: United States | participants | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients Achieving Clinical Response, measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of patients achieving complete response or partial response according to RECIST Criteria version 1.0. Its stated timeframe is 1 year. A complete or partial response is a category assigned using defined tumor-response criteria; the endpoint therefore counts patients whose assessments meet either category, rather than measuring survival or adverse events.
As a general statistical explanation, a response endpoint is used in a clinical study to describe whether tumor measurements meet prespecified criteria for response during the stated assessment period. For interpretation, the count needs a clear denominator: readers need to know how many participants were assessed and how missing or unevaluable assessments were handled. A count alone cannot establish the response proportion or the precision of that proportion.
The registry names the response categories and the criteria version, but it does not report the response count, the denominator used for an analysis, assessment timing details, or the handling of missing evaluations. It explicitly states that the study data had not been analyzed. As a result, the record defines the intended endpoint but does not give an estimate of the observed response outcome.
Response is distinct from the listed secondary outcomes of overall survival and participants experiencing adverse events. Each addresses a different aspect of study outcomes and requires its own definition and analysis. The registry does not provide results for those secondary outcomes either.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s intent and design, but it does not provide analyzed clinical results. In particular, the primary endpoint is defined as the number of patients with a complete or partial response under RECIST Criteria version 1.0 within 1 year, while the population description says the study data had not been analyzed. No response count or analyzed denominator is reported. Therefore, the response endpoint cannot be quantified from this record.
The registry lists 25 as the enrollment value. Enrollment is not, by itself, an analysis denominator. The record does not say how many participants received treatment, had an evaluable response assessment, or were included in an outcome analysis. It would be inappropriate to use the enrollment value as the denominator for a response estimate without that information.
The study used a single group, with no randomized comparator. Even if a response result were available, a single-group result would describe outcomes among the analyzed participants, not establish a comparative treatment effect. Differences between observed outcomes and outcomes in other settings could reflect differences in participants, assessment, follow-up, or other factors. No such cross-study comparison is reported in the registry.
The listed secondary outcomes are overall survival and the number of participants experiencing adverse events. The record does not report results for either outcome. In the adverse-event record, the regimen group has 0 at risk and 0 affected for the listed serious and other event summaries, and the deaths value is null. Because the at-risk counts are recorded as 0, those entries cannot be interpreted as showing that participants received treatment and experienced no adverse events. The record does not provide an evaluable safety population or outcome analysis.
The study status is terminated, but the reason for termination is not reported in the registry record. Termination alone does not identify whether recruitment, treatment, follow-up, data collection, or analysis was affected, and it does not explain why the primary results are absent. The dates and status provide study-history context, not evidence about clinical outcomes.
The registry lists 0 analyses. It does not report an analysis plan, a response estimate, an uncertainty interval, or an inferential test. Consequently, no conclusion about the magnitude or precision of response, survival, or adverse-event outcomes can be drawn from the posted results. Any planning illustrations based on an observed effect also lack a reported effect estimate to anchor them. They should not be mistaken for observed power or for findings from this trial.
9. Statistical Methods Explained
Statistical interpretation depends on the design, the endpoint definition, the participants included in an analysis, and the results actually reported. For this study, the registry identifies a phase II, single-group design and defines a primary response endpoint, but states that the study data had not been analyzed. These features set clear limits on what statistical conclusions can be made.
What does a single-group design estimate?
As a general explanation, a single-group study can estimate an outcome within the group that received the study regimen, provided the relevant outcome data and analysis population are available. For a response endpoint, that would ordinarily require both the count meeting the response definition and a stated denominator. An uncertainty interval can then describe how precisely the underlying response frequency is estimated from the observed participants. The registry does not provide the count, denominator, or interval for this study.
A single-group estimate is not a randomized treatment contrast. Without a control group, the observed outcomes cannot be compared under the protection against baseline differences that random allocation is intended to provide. The registry lists allocation as NA and describes a single group. There is no like-for-like comparator in the record, so an effect relative to another treatment cannot be estimated from these data.
Why does the endpoint definition matter?
The primary endpoint counts patients achieving complete response or partial response under RECIST Criteria version 1.0, with a stated timeframe of 1 year. A defined response rule helps make outcome classification more consistent. However, the definition does not by itself tell readers how many participants were assessed, whether all assessments were evaluable, or how unavailable assessments were treated. Those details matter because the denominator and missing-outcome approach affect the interpretation of a response count. They are not reported in the registry record.
Overall survival and the number of participants experiencing adverse events are listed as secondary outcomes. They are not interchangeable with response: each measures a different outcome and has distinct requirements for follow-up, event definitions, and analysis populations. Results and detailed definitions for those outcomes are not reported in the registry record.
What can confidence intervals and tests tell readers?
As a general explanation, a confidence interval expresses the precision of an estimate under the assumptions of the method used to calculate it. A narrower interval indicates greater precision, while a wider interval indicates greater uncertainty. A statistical test evaluates data against a specified null hypothesis under its assumptions. Neither a test result nor an interval replaces the need to know the endpoint, denominator, and analysis population.
No confidence interval, test result, or response estimate is reported for this study. The registry lists 0 analyses, and its primary-outcome population description says the study data had not been analyzed. There is therefore no trial-specific estimate to interpret for statistical significance or precision. No unadjusted recalculation can be made from the posted summary information.
How should planning illustrations be read?
As a general explanation, a sample-size calculation uses assumptions about a target effect, variability or event rates, significance level, allocation, and a chosen power. Its output is a planning illustration: it describes what a future design might require under those assumptions. It is not an observed property of a completed study and is not observed power.
The planning assumptions described in the registry use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect described as a stated fraction of an observed effect. The registry also says that such calculations are planning illustrations and not the trial’s own design. Those assumptions do not match this study’s recorded single-group structure. Moreover, the registry does not report an observed effect from which the illustrations could be grounded. Thus, no planning value can be treated as a result from this trial or as evidence about its statistical power.
General statistical methods can clarify how estimates and uncertainty would be interpreted if results were reported. They cannot substitute for missing study data, missing analysis details, or an unreported comparator. For this record, the sound interpretation is limited to its design and outcome definitions.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary outcome, number of patients achieving clinical response, and lists overall survival and participants experiencing adverse events as secondary outcomes. It also lists 3 outcome measures, but only two secondary outcomes are named in the record. The identity and definition of the remaining measure are not reported in the registry record.
Multiplicity arises when several outcomes, time points, subgroups, or statistical tests are considered. As a general explanation, testing multiple questions can increase the chance of obtaining an apparently notable finding by chance if the analysis does not account for the multiplicity or prioritize hypotheses in advance. A prespecified analysis plan can describe how primary and secondary outcomes will be interpreted and whether any adjustment or hierarchy is intended. The registry does not report such a plan, multiplicity adjustments, or the number of tests actually conducted; it lists 0 analyses.
The record does not report missing-data counts or the methods used to handle missing response assessments, survival follow-up, or adverse-event information. It also does not define an analysis population for the primary or secondary outcomes. These omissions matter because the participants eligible for each analysis may differ from the enrollment value, and the treatment of missing observations can affect estimates.
As a general explanation, complete-case analyses use participants with the necessary outcome information, while other approaches may use assumptions or models to address missing values. The appropriate interpretation depends on why data are missing and on the prespecified method. No method can be attributed to this study from the registry record. The record likewise does not report whether analyses were conducted in an intention-to-treat, treated, or evaluable population.
Because the primary outcome is described as not analyzed and the registry lists 0 analyses, there are no reported endpoint tests to adjust or interpret. No conclusion about multiplicity handling or missing-data robustness is possible.
11. What the Result Does, and Does Not, Mean
The record establishes that a phase II study of combination chemotherapy was registered for first-line treatment of metastatic gastric adenocarcinoma. It identifies a single-group design, describes the regimen, defines a primary response outcome, and lists secondary outcomes. These are details about the study’s planned focus and recorded design, not evidence of clinical benefit or harm.
The registry does not report an analyzed primary response result. It therefore does not show how many patients had a complete or partial response, how many were assessed, or how precise an estimate might be. It also provides no reported results for overall survival or adverse events. The adverse-event entries with 0 at risk cannot be read as proof that there were no events among treated participants.
The absence of reported analysis does not establish that no data were collected, nor does it establish that the regimen had a particular outcome. The registry says the study data had not been analyzed for the primary outcome and lists 0 analyses. The reason for termination and the reason outcome analyses are absent are not reported in the registry record.
Even if a within-group response result were available, the single-group design would not provide a randomized comparison against another treatment. An observed outcome in a single group does not, on its own, show what would have occurred under a different treatment or control condition. No comparative effect can be inferred from this record.
Accordingly, the useful interpretation is descriptive: the study addressed a defined clinical question, but the registry record does not provide outcome estimates with which to answer it. Statistical uncertainty cannot be assessed without estimates and their underlying analysis information. The record should not be treated as showing either a positive or a negative clinical result.
12. Why This Trial Matters Statistically
This trial is statistically instructive because its clinical question is more fully documented than its outcome analysis. The record identifies a phase II study, a single-group structure, a specific combination regimen, and a response endpoint based on RECIST Criteria version 1.0. At the same time, it says the primary study data had not been analyzed and lists 0 analyses. This contrast illustrates why a registered question and a reported result are not the same thing.
The design also clarifies the limits of inference. With no separate comparator and allocation listed as NA, the study cannot support a randomized treatment contrast. If a response estimate had been reported, its interpretation would still depend on the assessed population, denominator, response handling, and precision. Those details are not reported in the registry record.
The record further illustrates why registry outcome fields need to be interpreted in context. A zero recorded alongside a zero at-risk count does not establish that the treated group had no adverse events. Counts need an appropriate population and denominator before they can support a safety interpretation. Similarly, an enrollment value does not automatically identify the population analyzed for response or survival.
Planning assumptions also require alignment with design and available data. The listed planning approach assumes equal allocation between two arms, while the trial is recorded as single group, and the registry reports no observed effect estimate. Such illustrations cannot be read as trial findings or observed power. Overall, the study’s statistical importance lies in showing how design, reporting completeness, and the distinction between planned outcomes and analyzed results constrain interpretation.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is that the registry reports no analyzed primary outcome. It gives no response count, denominator, estimate, uncertainty interval, or test result. The primary outcome description explicitly says the study data had not been analyzed. Thus, the clinical question cannot be answered from the posted results.
The registry does not report the reason the study was terminated. It also does not report whether termination affected recruitment, treatment, follow-up, or outcome reporting. The status alone cannot be used to infer those circumstances.
The study has a single-group design and no randomized comparator. This limits the kinds of conclusions that could be drawn even if within-group outcomes were available: a comparative treatment effect would not be supported by the recorded design. The record also does not report participant flow, treatment exposure, baseline characteristics, analysis populations, or how many participants had evaluable response assessments.
Safety interpretation is similarly constrained. The adverse-event record lists zero at risk and zero affected for the displayed summaries, while the deaths value is null. With no evaluable at-risk population reported, these entries do not establish an absence of adverse events. The registry does not report detailed adverse-event results or follow-up information.
Finally, the statistical analysis plan, missing-data approach, multiplicity strategy, and sample-size justification are not reported in the registry record. The planning assumptions described for illustrations do not constitute the trial’s own design, and no observed effect is reported. These limitations mean that neither outcome magnitude nor statistical precision can be assessed from the record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery — NCT00448682.
- Registry record last updated 2017-02-07; status last verified 2016-12.
- Results first posted 2013-05-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NCT00448682 is a phase II, single-group study sponsored by the University of Miami of FUdR, leucovorin, oxaliplatin, and docetaxel as first-line treatment for metastatic gastric adenocarcinoma. The registry lists enrollment as 25, allocation as NA, masking as none, and status as terminated. The recorded start is 2005-06 and primary completion is 2009-12.
The primary outcome is the number of patients achieving complete or partial response by RECIST Criteria version 1.0 within 1 year. Overall survival and participants experiencing adverse events are listed as secondary outcomes. The registry says the primary study data had not been analyzed and lists 0 analyses. No clinical outcome estimates, analysis populations, or reason for termination are reported in the registry record.