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

• Occurrence of one or more adverse event in a patient [ Time Frame: From the Informed Consent Form (ICF) signature to the end of the study ] [ Designated as safety issue: No ]
• Overall distribution of intensity of adverse events [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]
• Occurrence of particular adverse events and their intensities [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
• Percent of patients completing study treatment [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
• Percent of patients with grade 1, 2 and 3 neuropathy [ Time Frame: at 28 days, 6 months and 12 months after last chemotherapy administration. ] [ Designated as safety issue: No ]
• Percent of intended dose delivered for 5-FU/LV and Oxaliplatin [ Time Frame: from the informed consent signed up to the end of the study ] [ Designated as safety issue: No ]
• Delays in scheduled dosing [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
• Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
• •Survival Analysis •Laboratory assay and vital signs ECOG and KPS [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
• Long term toxicity [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients

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.