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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Colonic Neoplasms

Treatments: Drug: Oxaliplatin (SR96669)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00275210

EFC3313

Details and patient eligibility

About

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)

Enrollment: 2,246 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)