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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan
PFS of 1st line treatment
Time frame: 2-years
OS
Time frame: 4-years
objective tumor response
Time frame: 1-year
PFS of 2nd line treatment
Time frame: 1-year
safety
Time frame: 4-years
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l-leucovorin (200mg/m2) Day 1, 15
400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1\~3 (48 hours) of each 28 day cycle.