PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer
Inclusion Criteria:
- Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)
- Assessment of KRAS 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)
- Absence of synchronous colorectal cancer
- Age ≥ 18 years and < 71 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.