MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Sanofi2,246 enrolled

Overview

To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer. Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,246

Conditions

Colonic Neoplasms

Interventions

Oxaliplatin (SR96669)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Main selection 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)· * Complete resection of the primary tumor without gross or microscopic evidence of residual disease * Treatment within 7 weeks following surgery * Age 18-75 years old * ECOG PS £ 2 * No prior chemo, immuno or radiotherapy

Locations (19)

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Vienna, Austria

Outcomes

Primary Outcomes

To to detect occurrence of relapse the following examinations have to be performed for 5 years:

Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,

Every year for chest X-ray and colonoscopy for non polyp free patient,

Every 3 years colonoscopy for polyp free patient

Secondary Outcomes

Every 2 weeks clinical and laboratory tests (hematological, creatinine and liver tests) for safety evaluation during treatment then every 6 months neurological examination Date of death for OS

Data from ClinicalTrials.gov

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