Inclusion criteria | Exclusion criteria |
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â—Ź Written informed consent provided. | â—Ź Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis. |
● Aged ≥18 years with histologically confirmed adenocarcinoma of the colon or rectum (with or without the primary tumour in situ). | ● Previous radiation therapy to the upper abdomen. |
â—Ź Proven liver metastases. | â—Ź Non-malignant disease that renders patients unsuitable for the study treatment. |
● WHO performance status of 0–1. | ● Grade >1 peripheral neuropathy (NCI-CTCv3). |
● Life expectancy of ≥3 months. | ● Previous dose-limiting toxicity associated with adjuvant 5-FU or oxaliplatin chemotherapy. |
● Patients with additional limited extra-hepatic metastases in the lung or lymph nodes (fewer than 5 nodules ≤1 cm diameter or a single nodule ≤1.7 cm diameter in the lung, and lymph node involvement in a single anatomical area <2 cm diameter) with the aim of these patients being <40% of the total number of patients recruited (but not being excluded even if they account for more than this proportion). | ● Pregnancy or breast-feeding. |
â—Ź Chemotherapy-naĂŻve for mCRC, but previous adjuvant systemic chemotherapy for primary CRC or neoadjuvant chemo-radiotherapy to the pelvis more than 6 months before recruitment are permitted. | â—Ź Current or history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. |
â—Ź Deemed suitable for either treatment regimen by the investigator. | â—Ź Allergy to non-ionic contrast agents. |
â—Ź Adequate haematological, renal and hepatic function. | |
â—Ź Using an acceptable method of contraception. |