ECKINOXEPRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer

Fecha de inicio: 1 de mayo de 2012

Inclusion Criteria: Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge) Assessment of RAS status of the primary colon cancer on biopsies (WT or mutated) Colon cancer classified: poor prognosis T3 (T3 bad) - T4 and/ or N2 by abdominal CT scan. Non metastatic colon cancer (lung, liver, peritoneal) Non complicated primary tumor (obstruction, perforation, bleeding), patients with cancer treated by stomie de derivation may be included in the study. DPD deficency Absence of synchronous colorectal cancer Age ≥ 18 years and < 76 years ECOG performance status 0-1 No prior chemotherapy within the last 5 years No prior abdominal or pelvic irradiation within the last 5 years Life expectancy of 5 years or more No history of colorectal cancer within the last 5 years Patients with childbearing potential should use effective contraception during the study and the following 6 months White blood cell count of 3 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more Total bilirubin of 1.5 x ULN (upper limit of normal) or less ASAT and ALAT of 2.5 x ULN or less Alkaline phosphatase of 1.5 x ULN or less Serum creatinine of 1.5 x ULN or less Signed written informed consent obtained prior to any study specific screening procedures Exclusion Criteria: contra-indication to iodinated contrast medium injection including allergy to iodinated contrast medium and renal insufficiency proscribing iodinated injection Age > 70 years Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery Complicated primary colon cancer (obstruction, bleeding, perforation) Synchronous colorectal cancer Metastatic spread at baseline assessment (lung, liver, peritoneal) History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Known hypersensitivity reaction to any of the components of study treatments Presence of inflammatory bowel disease HNPCC syndrome or polyposis Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period Previous malignancy in the last 5 years Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent Any significant disease which, in the investigator's opinion, would exclude the patient from the study.