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.