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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

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).

â—Ź 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.

â—Ź Grade >1 peripheral neuropathy (NCI-CTCv3).

● Life expectancy of ≥3 months.

â—Ź 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).

â—Ź 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.