drugset / Trial / NCT00349492

A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

NCT00349492 ↗

Phase 3 Completed 372 enrolled Clinical Research Center for Solid Tumor, Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1.5 years

Timeline

Start
2006-06
Primary completion
2011-12
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified — Intravenous
Comparator Irinotecan Small molecule — Intravenous