A Randomised Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Proapectively the Prognostic Value of Molecular Markers

INTERVENTION: Trade Name: Avastin Product Name: Bevacizumab Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Calcium Pharma Plc Product Name: Calcium Leucovorin Product Code: V03AF03 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Oxaliplatin Product Name: Oxaliplatin Product Code: L01XA03 Pharmaceutical Form: Powder for solution for infusion Trade Name: Fluorouracil Product Name: Fluorouracil Product Code: L01BC02 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Fluorouracil Product Name: Fluorouracil Product Code: L01BC02 Pharmaceutical Form: Concentrate for solution for infusion CONDITION: Stage II colon cancer. ; MedDRA version: 9.1 Level: PT Classification code 10009954 Term: Colon cancer stage II PRIMARY OUTCOME: Main Objective: To demonstrate an improvement in 3‐year disease‐free survival for high‐risk stage II colon cancer patients randomly assigned to 5‐FU, leucovorin, oxaliplatin versus 5‐FU, leucovorin, oxaliplatin and bevacizumab. Primary end point(s): Disease Free survival at 3 years. Secondary Objective: To compare overall survival between the regimes.; ; To further define the toxicity profiles of the regimens.; ; To prospectively determine the impact of tumour biological characteristics on the survival of patients with stage II colon cancer. INCLUSION CRITERIA: The distal extent of the tumour must be >/= 12cm from the anal verge. Patients must have a paraffin‐embedded tumour specimen available for the evaluation of risk that is less than 50 days old. A histologically confirmed adenocarcinoma of the colon that meets Stage II carcimona criteria. >/= 8 lymph nodes must have been evaluated and reported. Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease free for >/= 5 years and are deemed by their physician to be at low risk of recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomisation. Patients must be >/= 18 years old. Patients must have ECOG performance status of 0‐2. Patient must, within