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 thestudy and the following 6 months

• Adequate bone marrow function : white blood cell count of 2 x 109/L or more withneutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobinof 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 (upperlimits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less

• Adequate renal function : GFR (Glomerular Filtration Rate) > 50ml/min by Wright orCockcroft formula

• Signed written informed consent obtained prior to any study specific screeningprocedures

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 inthe 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 wouldnot permit the patient to complete the study or sign informed consent

• Any significant disease which, in the investigator's opinion, would exclude thepatient from the study