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Brief Title: IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Official Title: Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
Study ID: NCT00316745
Brief Summary: This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).
Detailed Description: A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine), Sapporo, Hokkaido, Japan
Name: Yoshito Komatsu, MD, PhD
Affiliation: Hokkaido Gastrointestinal Cancer Study Group
Role: STUDY_CHAIR