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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Oxaliplatin

Criteria

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.