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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00275210
First received: January 3, 2006
Last updated: April 17, 2009
Last verified: April 2009
  Purpose

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)


Condition Intervention Phase
Colonic Neoplasms
Drug: Oxaliplatin (SR96669)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 2246
Study Start Date: October 1998
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275210

  Show 19 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Aimery de Gramont, MD Hopital saint-Antoine, Oncology department
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00275210     History of Changes
Other Study ID Numbers: EFC3313
Study First Received: January 3, 2006
Last Updated: April 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: National Health Service
Spain: Ministry of Health

Keywords provided by Sanofi:
Oxaliplatin
Chemotherapy,adjuvant
Colonic Neoplasms

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014