Table 1 Inclusion and exclusion criteria
Inclusion criteria | Exclusion criteria |
|---|---|
• Non-complicated primary tumor (i.e. tumor without obstruction, bleeding, abscess or perforation requiring emergency surgery and/or contra-indicating first-line chemotherapy) | • Rectal tumor operated before inclusion |
• Unresectable synchronous metastases | • Resectable metastases |
• Rectal adenocarcinoma (<15 cm from the anal verge) with few or no symptoms and unresectable metastasis (assessed by the investigator) unsuitable for curative treatment | • Symptoms related to the rectal tumor requiring first intention rectal surgery (appreciated by investigator) |
• No known unresectable primary tumor (with clear margin > 1 mm) on CT-scan and MRI | • Contra-indication for surgery |
• No disease progression under chemotherapy (for at least 4 cycles) | • Complicated (obstruction, bleeding, abscess, perforation) primary tumor requiring emergency surgery and/or contra-indicating first line-chemotherapy |
• Assessment of KRAS status before randomization (wild type or mutated) |  |
• ECOG performance status 0-1 | • Non-resectable primary tumor (with wild margin) |
• Life expectancy without cancer >2 years | • Under nutrition (albumin < 30 g/l) |
• White blood cell count ≥ 3 × 109/L, with neutrophils ≥ 1,5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l) | • Peritoneal carcinomatosis |
• Total bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 × ULN, alkaline phosphatase ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN | • Disease progression under chemotherapy (RECIST 1.1 criteria) |
• Age ≥ 18 years ≤ 75 years | • Known hypersensitivity reaction or specific contraindications to any of the components of study treatments |
• Patients with childbearing potential should use effective contraception during the study and the following 6 months | • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia |
• Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research | • Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding |
• Signed written informed consent obtained prior to any study-specific screening procedure | • Previous malignancy in the last 5 years |