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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275210
• Other study ID #: EFC3313
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2006
• Last updated: April 17, 2009
• Start date: October 1998
• Est. completion date: April 2003

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: National Health ServiceSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2246
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Drug:
• Oxaliplatin (SR96669)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Singapore,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

André 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 Col — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Primary	Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
Primary	Every year for chest X-ray and colonoscopy for non polyp free patient,
Primary	Every 3 years colonoscopy for polyp free patient
Secondary	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