Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

INTERVENTION: Group A:mFOLFOX6 Day 1 day 2 day 14 L‐OHP 2HR l‐LV 200mg/m2 5‐FU 2,400mg/m2 civ 2HR 46HR ‐‐‐‐‐‐‐‐‐‐‐‐‐ | 5‐FU 400mg/m2 iv Rapid Group B:TS‐1/CPT‐11 CPT‐11 80 mg/m2 CPT‐11 80 mg/m2 1.5 hours 1.5 hours TS‐1 40‐60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks). CONDITION: Patients with advanced and/or recurrent colorectal cancer PRIMARY OUTCOME: Response Rate(RECIST) SECONDARY OUTCOME: Overall Survival, Progression Free Survival, Adverse Events, Incidence of Recruitement INCLUSION CRITERIA: 1) colon cancer proven histologically 2) with measurable metastatic lesions 3) without prior chemotherapy or with chemotherapy which is completed Before 6 months of registration 4) without radiation therapy 5) age: =>20 and 75=> 6) Performance Status: 0‐1 (ECOG criteria) 7) more than 3 months of Expected survival period 8) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Neutrocyte: => 2,000/mm3 O Platelet: >= 100,000/mm3 O Hb: >= 9.0 g/dl O sGOT,sGPT: 2.5 times of normal range in each institute O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute O Ccr from Cockcroft‐Gault's method: >= 50 ml/min O ECG: normal range 9) written informed consent 10) patients who can take food orally