Status:
COMPLETED
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Lead Sponsor:
Sanofi
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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), saf...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
2246 Patients enrolled
Trial Details
Trial ID
NCT00275210
Start Date
October 1 1998
End Date
April 1 2003
Last Update
April 20 2009
Active Locations (19)
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1
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
2
Sanofi-Aventis Administrative Office
Vienna, Austria
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
Hørsholm, Denmark