This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
CLASSIC was a phase 3 randomized parallel-group treatment trial evaluating capecitabine and oxaliplatin in patients with stomach neoplasms.
| Feature | CLASSIC |
|---|---|
| Condition | Stomach Neoplasms |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Lead sponsor | Sanofi |
2. Clinical Question
Population
Patients with stomach neoplasms enrolled in a phase 3 randomized treatment study.
Intervention
Capecitabine and oxaliplatin.
Comparator
The registry identifies two study arms but does not provide additional comparator details in the available record.
Primary question
The trial evaluated clinical outcomes associated with the randomized treatment comparison.
3. Trial Design
The CLASSIC trial used randomized allocation, a parallel design, no masking, and a treatment-focused phase 3 framework.
| Design element | Description |
|---|---|
| Enrollment | 1035 participants |
| Arms | 2 |
| Interventions | Capecitabine (drug); Oxaliplatin (drug) |
| Status | Completed |
| Primary completion date | 2012-11 |
4. Endpoints
| Endpoint | Time frame |
|---|---|
| Recurrence of the original cancer | From the beginning to end of the study |
| Development of a new gastric cancer | From beginning to end of study |
| Death due to any cause | From the beginning to the end of study |
| Adverse events | From beginning to end of study |
| Clinical laboratory tests | From beginning to end of study |
5. Planned Analysis
The registry identifies recurrence, new gastric cancer, death due to any cause, adverse events, and clinical laboratory tests as primary endpoints. No results or formal statistical analyses were posted on ClinicalTrials.gov.
For recurrence and death endpoints, randomized clinical trials typically use time-to-event methods such as Kaplan-Meier estimation, log-rank comparisons, and regression models for treatment-effect estimation. Safety and laboratory outcomes are generally summarized using descriptive statistics and comparative summaries.
6. Statistical Methodology
Time-to-event analysis
Endpoints involving recurrence or death are commonly evaluated by estimating the time until an event occurs. Patients without an event at the end of follow-up contribute information until their last assessment through censoring.
Randomized treatment comparison
Randomization is designed to balance measured and unmeasured factors between groups, allowing differences in outcomes to be interpreted within the framework of the assigned treatment comparison.
Safety analysis
Adverse events and clinical laboratory tests are evaluated separately from efficacy outcomes because treatment benefit and toxicity represent different dimensions of trial evidence.
7. Statistical Methods Explained
How would recurrence typically be analyzed?
Recurrence endpoints are often analyzed as time-to-event outcomes, where the analysis accounts for patients who have not yet experienced recurrence at the time of analysis.
Why is randomization important?
Randomization reduces systematic differences between treatment groups and supports unbiased comparison of outcomes.
What does censoring mean?
Censoring occurs when the exact event time is not observed for every participant. Appropriate survival methods incorporate available follow-up information.
Why are safety outcomes analyzed separately?
A treatment may affect efficacy and safety differently, so adverse events require their own summaries and interpretation.
8. Limitations
- The ClinicalTrials.gov record does not report efficacy estimates, confidence intervals, p-values, subgroup analyses, or event counts.
- The registry does not provide detailed baseline characteristics or analysis populations.
- Without posted statistical analyses, quantitative treatment-effect interpretation cannot be reconstructed from the registry record alone.
9. Why This Trial Matters Statistically
CLASSIC illustrates several fundamental concepts in clinical-trial statistics: randomized allocation, parallel-group design, time-to-event endpoints, safety evaluation, and the distinction between planned outcomes and reported analyses.
| Concept | Role in CLASSIC |
|---|---|
| Randomization | Supports comparison of two assigned treatment groups |
| Parallel design | Patients are evaluated within concurrent study arms |
| Time-to-event methods | Relevant for recurrence and death outcomes |
| Safety analysis | Evaluates adverse events and laboratory findings |
10. Related Tutorials
No related tutorial cards are available for this trial.
11. Related Calculators
No related calculator cards are available for this trial.
12. Sources
- ClinicalTrials.gov: CLASSIC (NCT00411229)
- PubMed: Publication record
- PubMed: Publication record
- PubMed: Publication record