ADJUVANT TREATMENT OF FULLY RESECTED STAGE III COLON CANCER WITH FOLFOX-4 VERSUS FOLFOX-4 PLUS CETUXIMAB Tratamiento adyuvante con FOLFOX-4 versus FOLFOX-4 + cetuximab para el cáncer de colon en estadio III extirpado completamente - PETACC 8
- Conditions
- FULLY RESECTED STAGE III COLON CANCERCANCER DE COLON EN ESTADIO III EXTIRPADO COMPLETAMENTE
- Registration Number
- EUCTR2005-003463-23-ES
- Lead Sponsor
- Fédération Francophone de Cancérologie Digestive (FFCD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
- Age > or = 18 and <75 years
- Pathologically confirmed stage III adenocarcinoma of the colon, regardless of EGFR status,
- Curative R0 resection performed between 28 and 56 days prior to randomization
- No prior chemotherapy
- No prior abdominal or pelvic irradiation
- WHO performance status: 0 or 1
- Signed written informed consent obtained prior to any study specific screening procedures
- Patients with childbearing potential should use effective contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Distant metastatic disease
- Inflammatory bowel disease
- Rectal cancer located within 15 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery or having received radiation therapy prior to surgery
- Pregnant or breast-feeding woman
- Neuropathy
- Known hypersensitivity reaction to any of the components of study treatments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method