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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00275210

Collaborator

(none)

2,246

Enrollment

Locations

Duration (Months)

118.2

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Drug: Oxaliplatin (SR96669)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

2246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1998

Actual Primary Completion Date :

Apr 1, 2003

Actual Study Completion Date :

Apr 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales	Australia
2	Sanofi-Aventis Administrative Office	Wien		Austria
3	Sanofi-Aventis Administrative Office	Diegem		Belgium
4	Sanofi-Aventis Administrative Office	Horsholm		Denmark
5	Sanofi-Aventis Administrative Office	Paris		France
6	Sanofi-Aventis Administrative Office	Berlin		Germany
7	Sanofi-Aventis Administrative Office	Athens		Greece
8	Sanofi-Aventis Administrative Office	Budapest		Hungary
9	Sanofi-Aventis Administrative Office	Natanya		Israel
10	Sanofi-Aventis Administrative Office	Milano		Italy
11	Sanofi-Aventis Administrative Office	Gouda		Netherlands
12	Sanofi-Aventis Administrative Office	Lysaker		Norway
13	Sanofi-Aventis Administrative Office	Warszawa		Poland
14	Sanofi-Aventis Administrative Office	Porto Salvo		Portugal
15	Sanofi-Aventis Administrative Office	Singapore		Singapore
16	Sanofi-Aventis Administrative Office	Barcelona		Spain
17	Sanofi-Aventis Administrative Office	Bromma		Sweden
18	Sanofi-Aventis Administrative Office	Geneva		Switzerland
19	Sanofi-Aventis Administrative Office	Guildford Surrey		United Kingdom