NCT00349492

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

Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Clinical Research Center for Solid Tumor, Korea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IP	irinotecan+cisplatin

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-12-01
• Completion: 2013-10-01
• First posted: 2006-07-07
• Last updated: 2013-12-04

Locations

14 sites across 1 country: South Korea