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

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: SR96669/Oxaliplatin	Phase III

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Fluorouracil Oxaliplatin

U.S. FDA Resources

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

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

Estimated Enrollment:	2200
Study Start Date:	October 1998
Estimated Study Completion Date:	April 2003

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Chair:	Aimery de Gramont, MD	Hopital saint-Antoine, Oncology department

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	EFC3313, SR96669
First Received:	January 3, 2006
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00275210
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

Study placed in the following topic categories:

Oxaliplatin

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Fluorouracil

Colonic Diseases

Gastrointestinal Neoplasms

Intestinal Diseases

Colonic Neoplasms

Intestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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