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

This study has been completed.

First Received: January 3, 2006 Last Updated: April 17, 2009 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00275210

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

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

Hide Study Locations

Locations

Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Austria
Sanofi-aventis Administrative Office
Wien, Austria
Belgium
Sanofi-aventis Administrative Office
Diegem, Belgium
Denmark
Sanofi-aventis Administrative Office
Horsholm, Denmark
France
Sanofi-aventis Administrative Office
Paris, France
Germany
Sanofi-aventis Administrative Office
Berlin, Germany
Greece
Sanofi-aventis Administrative Office
Athens, Greece
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-aventis Administrative Office
Natanya, Israel
Italy
Sanofi-aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-aventis Administrative Office
Porto Salvo, Portugal
Singapore
Sanofi-aventis Administrative Office
Singapore, Singapore
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-aventis Administrative Office
Geneva, Switzerland
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

Aimery de Gramont, MD

Hopital saint-Antoine, Oncology department

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC3313
Study First Received:	January 3, 2006
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00275210 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; United Kingdom: National Health Service; Spain: Ministry of Health

Keywords provided by Sanofi-Aventis:

Oxaliplatin
Chemotherapy,adjuvant
Colonic Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Adjuvants, Immunologic
Intestinal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009