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Table 1 FOXFIRE Inclusion/Exclusion criteria

From: FOXFIRE protocol: an open-label, randomised, phase III trial of 5-fluorouracil, oxaliplatin and folinic acid (OxMdG) with or without interventional Selective Internal Radiation Therapy (SIRT) as first-line treatment for patients with unresectable liver-only or liver-dominant metastatic colorectal cancer

Inclusion criteria Exclusion criteria
1. Histologically confirmed colorectal cancer (CRC) with liver-only or liver-dominant metastases not amenable to curative surgical resection confirmed at a Multi-disciplinary team (MDT) meeting 1. Liver metastases amenable to curative resection, unless limited EHD
2. Unequivocal & measurable CT evidence of liver metastases, not treatable by surgical resection or local ablation with curative intent at time of trial entry 2. Pregnant or breast-feeding
3. Age ≥ 18 years 3. Evidence of ascites, cirrhosis or portal hypertension
4. WHO performance status of 0–1 4. Main portal venous tumour involvement or thrombosis
5. Life expectancy > 3 months 5. Previous radiotherapy to upper abdomen or upper lumbar spine
6. Adequate haematological, renal and hepatic function 6. Other active malignancy within last 5 years [excluding colorectal cancer and other non-melanoma skin cancers]
7. Eligible for systemic chemotherapy as 1st line treatment for metastatic CRC 7. Non-malignant disease that would render patient ineligible at the discretion of the Investigator
8. Liver only/limited extra-hepatic disease (EHD): metastases in the lung must not be more than 5 in number and should be, in the opinion of either the local multi-disciplinary team (MDT) or following central review of scans arranged via the Trials Office, amenable to future definitive local therapy. In addition to lung metastases, a single site of other extra-hepatic disease is permitted (e.g. multiple lymph nodes in one lymph node region) after approval by the Trials Office. 8. Equivocal, immeasurable, or unevaluable liver metastases
9. Patients are permitted to have a primary colorectal tumour in situ, which should be potentially resectable following protocol therapy 9. Unequivocal evidence of bone metastasis
10. Suitable for all aspects of treatment determined by clinical assessment undertaken by Investigator 10. DLT associated with previous 5-FU or oxaliplatin chemotherapy
11. Using adequate contraception if pre-menopausal (male and female patients) 11. Previous chemotherapy for metastatic colorectal cancer [last dose of adjuvant chemotherapy for CRC administered ≥ 6 months pre-randomisation]
12. Willing & able to provide written informed consent 12. Peripheral neuropathy > CTCAE Grade 1