A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
NCT00349492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372
Last updated 2013-12-04
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
Interventions
- DRUG
-
IP
irinotecan+cisplatin
Sponsors & Collaborators
-
Clinical Research Center for Solid Tumor, Korea
lead OTHER
Principal Investigators
-
Dae Seog Heo, MD, PhD · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2011-12-31
- Completion
- 2013-10-31
Countries
- South Korea
Study Locations
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