Trial Information
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To to detect occurrence of relapse the following examinations have to be performed for 5 years:
Principal Investigator
Aimery de Gramont, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital saint-Antoine, Oncology department
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
EFC3313
NCT ID:
NCT00275210
Start Date:
October 1998
Completion Date:
April 2003
Related Keywords:
- Colonic Neoplasms
- Oxaliplatin
- Chemotherapy,adjuvant
- Colonic Neoplasms
- Neoplasms
- Colonic Neoplasms