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Table 1 Patient eligibility criteria for SIRFLOX study

From: Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study

Inclusion criteria Exclusion criteria
Written informed consent provided. 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.
Proven liver metastases. 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.
Chemotherapy-naïve 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. Current or history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
Deemed suitable for either treatment regimen by the investigator. Allergy to non-ionic contrast agents.
Adequate haematological, renal and hepatic function.  
Using an acceptable method of contraception.