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