Clinical Trial: MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
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 Summary:
Sponsor: Sanofi
Current Primary Outcome:
- 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
Original Primary Outcome:
- 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
Current Secondary Outcome: 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
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: January 3, 2006
Date Started: October 1998
Date Completion:
Last Updated: April 17, 2009
Last Verified: April 2009