Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

Inclusion criteria

• Pathologically confirmed colon adenocarcinoma (> 15 cm from the anal verge)
• Radiologic T3/T4 and high risk features by CT scan
• No metastasis on CT or PET(positron emission computed tomography)
• Age ≥ 18 and ≤ 70 years
• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• No history of colorectal cancer within 5 years
• No history of chemotherapy
• Patients with childbearing potential should use effective contraception during the study and the following 6 months
• Adequate bone marrow function : white blood cell count of 2 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
• Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
• Adequate renal function : GFR (Glomerular Filtration Rate) > 50ml/min by Wright or Cockcroft formula
• Signed written informed consent obtained prior to any study specific screening procedures

Exclusion criteria

• Age > 70 years and < 18 years
• Rectal cancer : 15 cm or less from the anal verge
• Complicated colon cancer (complete obstruction, perforation, bleeding)
• Metastatic colon cancer
• Known hypersensitivity reaction to any of the components of study treatments
• Inflammatory bowel disease
• Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
• Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Pregnancy or breast-feeding period
• Serious non-healing wound or bone fracture
• 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