drugset / Trial / NCT00144989
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
Phase 3
Completed
281 enrolled
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
Timeline
- Start
- 2002-09
- Primary completion
- 2011-09
- Completion
- 2011-09
Outcome
Missed primary endpoint
paper overall survival did not differ between the two groups (hazard ratio 1.09 [95% CI 0.80-1.46], one-sided stratified log-rank p=0.70). PMID 24309370 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etoposide | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | 60 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |