Colonic Neoplasms
Conditions
Keywords
Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms
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)
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed