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

Phase 3

Completed

• Conditions: Colonic Neoplasms

• Registration Number: NCT00275210
• Lead Sponsor: Sanofi

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-17
• Last Update Posted: 2009-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom

sanofi-aventis Australia & New Zealand administrative office; 🇦🇺 Macquarie Park, New South Wales, Australia