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

NCT ID: NCT00263055

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

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

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oxaliplatin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Claude Valterio, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Beijing, , China

Sanofi-Aventis

Hong Kong, , Hong Kong

Sanofi-aventis

Seoul, , South Korea

Sanofi-Aventis

Taipei, , Taiwan

Sanofi-Aventis

Bangkok, , Thailand

Countries

China; Hong Kong; South Korea; Taiwan; Thailand

Other Identifiers

R_9262

Identifier Type: -

Identifier Source: org_study_id