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

Study Overview
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Brief Summary
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Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients

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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dose-limiting toxicity |  | from the inform consent signed up to the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of one or more adverse event in a patient |  | From the Informed Consent Form (ICF) signature to the end of the study | 
| Overall distribution of intensity of adverse events |  | from the inform consnet signed up to the end of the study | 
| Occurrence of particular adverse events and their intensities |  | from the inform consent signed up to the end of the study | 
| Percent of patients completing study treatment |  | from the inform consent signed up to the end of the study | 
| Percent of patients with grade 1, 2 and 3 neuropathy |  | at 28 days, 6 months and 12 months after last chemotherapy administration. | 
| Percent of intended dose delivered for 5-FU/LV and Oxaliplatin |  | from the informed consent signed up to the end of the study | 
| Delays in scheduled dosing |  | During the study conduct | 
| Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment |  | during the study conduct | 
| •Survival Analysis •Laboratory assay and vital signs ECOG and KPS |  | during the study conduct | 
| Long term toxicity |  | during the study conduct |