MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV

Inclusion Criteria: Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin). Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease Patients must be entered in the study in order to start treatment within 7 weeks after surgery Age 18-75 years old Performance Status ≤ 2 (Karnofsky > or = 60%) No previous chemotherapy, immunotherapy or radiotherapy No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children Signed informed consent obtained prior to study entry Exclusion criteria Pregnant or lactating women Women of child bearing potential not using a contraceptive method Previous cancer of the colon or rectum Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years Participation in another clinical trial with any investigational drug within 30 days prior to randomization Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I) Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia History of significant neurologic or psychiatric disorders Active infection The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.