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
TAILOR was a randomized phase 3 parallel-group treatment trial comparing erlotinib with docetaxel in non small cell lung cancer.
| Feature | TAILOR |
|---|---|
| NCT ID | NCT00637910 |
| Title | Tarceva Italian Lung Optimization tRial |
| Condition | Non Small Cell Lung Cancer (NSCLC) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Interventions | Erlotinib and docetaxel |
2. Clinical Question
Population
Patients with non small cell lung cancer.
Intervention
Erlotinib treatment.
Comparator
Docetaxel treatment.
Primary question
Does erlotinib improve overall survival compared with docetaxel?
3. Trial Design
Patients were assigned using a randomized design.
The trial included two treatment arms.
Started 2007-11 with primary completion in 2012-02.
Lead sponsor: Fatebenefratelli and Ophthalmic Hospital.
4. Endpoints
| Endpoint | Definition |
|---|---|
| Overall Survival | Time frame: 12 months after the last patient is randomized |
5. Statistical Methodology
The registry identifies overall survival as the primary endpoint. Overall survival is a time-to-event outcome and is commonly analyzed using methods designed for censored survival data.
Time-to-event analysis
For overall survival, statistical analyses typically account for patients who have not experienced death by the end of follow-up through censoring. Common approaches include Kaplan-Meier estimation, log-rank comparisons, and Cox proportional-hazards modeling when prespecified in a statistical analysis plan.
6. Planned Analysis
The registry identifies Overall Survival as the primary endpoint with assessment at 12 months after the last patient is randomized.
For an endpoint of this type, investigators typically estimate survival over time and compare treatment groups using survival-analysis methods. Results have not been posted on ClinicalTrials.gov.
7. Statistical Methods Explained
Why is overall survival a time-to-event endpoint?
Overall survival measures the time until death, meaning patients may contribute different amounts of follow-up information.
Why is censoring important?
Censoring allows patients without an observed event during follow-up to contribute information up to their last known status.
What does randomization contribute statistically?
Randomization helps create comparable treatment groups and supports unbiased comparison of outcomes.
Why are hazard ratios often used for survival outcomes?
A hazard ratio summarizes relative event rates over follow-up when a proportional-hazards model is appropriate.
8. Limitations
- The ClinicalTrials.gov record does not report posted statistical analyses or efficacy estimates.
- Baseline characteristics, subgroup analyses, and safety results by arm are not reported in the registry information.
- Without posted results, treatment effects cannot be quantified from the registry record.
9. Why This Trial Matters Statistically
TAILOR illustrates several important principles in randomized oncology trials:
| Concept | Application |
|---|---|
| Randomization | Comparison of two treatment strategies |
| Time-to-event analysis | Overall survival as the primary endpoint |
| Censoring | Handling incomplete follow-up in survival analysis |
| Phase 3 design | Confirmatory clinical evaluation |