Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302
A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with
histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this
regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free
survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective tumor response
1-year
Yoshito Komatsu, MD.PhD
Study Chair
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare
HGCSG0302
NCT00209651
January 2004
December 2007
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