Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer:Hokkaido Gastrointestinal Cancer Study Group:HGCSG0001
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients
with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil.
The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by
the disease-free survival rate (DFR), median survival time (MST), incidence and severity of
adverse event.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective tumor response
Masahiro Asaka, MD, PhD
Study Chair
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare
HGCSG0001
NCT00209625
April 2000
November 2004
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