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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
irinotecan+cisplatin
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Yeungnam University Hospital
Daegu, South Korea
Daegu Catholic University Hospital
Daegu, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Yonsei Cancer Center
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Kangnam St.Mary's Hospital
Seoul, South Korea
...and 4 more locations
Overall survival
Time frame: month
Objective response rate
Time frame: percent
Progression free survival
Time frame: month
Safety profile
Time frame: percent
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