Background
Impact on survival of primary tumor resection in patients with CRC and unresectable metastases
Impact on quality of life of primary tumor resection in patients with CRC and unresectable metastases
Complications related to unresected primary tumors
Management of chemotherapy in the presence of the primary tumor
Morbidity of primary tumor resection in the setting of unresectable metastasis
Patient selection for primary tumor resection
Methods/Design
Protocol overview
Participants
Inclusion criteria | Exclusion criteria |
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• 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 |