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
FLOT4 was a randomized phase 2/3 treatment trial evaluating perioperative chemotherapy regimens in patients with locally advanced, resectable gastric cancer.
| Feature | FLOT4 |
|---|---|
| Condition | Gastric Cancer |
| Design | Randomized, parallel assignment |
| Masking | None |
| Primary purpose | Treatment |
| Enrollment | 716 |
| Sponsor | Krankenhaus Nordwest |
| Status | Completed |
2. Clinical Question
Population
Patients with locally advanced, resectable gastric cancer.
Intervention
5-Fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT).
Comparator
Epirubicin, cisplatin and 5-fluorouracil (ECF).
Primary question
Whether the FLOT regimen should be compared with ECF for the registered primary endpoint of median overall survival.
3. Trial Design
Randomization
716 patients
Parallel groups
2 arms
Treatment
FLOT vs ECF
Follow-up
2 years
Analysis
Overall survival
FLOT arm
5-Fluorouracil, leucovorin, oxaliplatin and docetaxel.
ECF arm
Epirubicin, cisplatin and 5-fluorouracil.
4. Endpoints
| Endpoint | Time frame |
|---|---|
| Median overall survival | 2 years follow-up |
5. Planned Analysis
The registry identifies median overall survival as the primary endpoint with a time frame of 2 years follow-up. No statistical analyses are posted in the ClinicalTrials.gov record.
Overall survival analysis
For randomized oncology trials, overall survival is commonly evaluated using time-to-event methods. Typical analyses include Kaplan-Meier estimation to describe survival over time, log-rank testing to compare randomized groups, and Cox proportional-hazards models to estimate relative treatment effects.
6. Statistical Methodology
Randomization
Randomization creates comparable treatment groups on average and provides the foundation for causal comparison between the assigned interventions.
Time-to-event analysis
Overall survival is a time-to-event endpoint because patients may have different follow-up durations. Censoring allows patients without an observed event at the last follow-up time to contribute available information.
Median survival
The median overall survival is the time at which the estimated survival probability reaches 50%. It summarizes the center of the survival distribution rather than describing every patient's outcome.
7. Statistical Methods Explained
Why is overall survival a time-to-event endpoint?
Death can occur at different times for different patients, so the analysis must incorporate both event times and varying follow-up duration.
Why use Kaplan-Meier estimation?
Kaplan-Meier methods estimate survival probabilities while accounting for patients whose follow-up ends before the event is observed.
What does a hazard ratio measure?
A hazard ratio compares estimated instantaneous event rates between groups over the analyzed follow-up. It is not the same as a ratio of median survival times.
Why does randomization matter?
Randomization reduces systematic differences between groups, allowing observed outcome differences to be interpreted in relation to the assigned treatments.
Why is confidence interval reporting important?
Confidence intervals describe uncertainty around an estimated effect and provide information about precision.
8. Limitations
- The ClinicalTrials.gov record does not report posted statistical analyses for the primary endpoint.
- Results, estimates, confidence intervals and p-values are not available in the registry record used for this analysis.
- Without posted analyses, treatment-effect estimates cannot be evaluated from the registry information alone.
9. Why This Trial Matters Statistically
| Concept | Application |
|---|---|
| Randomization | Comparison of two treatment strategies in parallel groups. |
| Time-to-event analysis | Primary endpoint based on overall survival. |
| Censoring | Required when follow-up differs among patients. |
| Median survival | Summary measure for survival distributions. |