FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

Inclusion Criteria:

- Age 18 years or older

- Willing and able to provide written informed consent

- Unequivocal and measurable CT evidence of liver metastases which are not treatable by
surgical resection or local ablation

- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung:
5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one
single anatomic area (pelvis, abdomen or chest): any number, < 2 cm)

- All imaging evidence used as part of the screening process must be within 28 days

- Suitable for either treatment regimen

- WHO performance status 0-1

- Adequate hematological, renal and hepatic function

- Life expectancy of at least 3 months without any active treatment

Exclusion Criteria:

- Evidence of ascites, cirrhosis, portal hypertension, main portal or venous
involvement or thrombosis as determined by clinical or radiologic assessment

- Previous radiotherapy delivered to the liver

- Non-malignant disease that would render the patient unsuitable for treatment
according to the protocol

- Peripheral neuropathy > grade 2 (NCI-CTC)

- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin
chemotherapy

- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
colorectal cancer is permitted provided that it was completed more than 6 months
before entry into the study

- Pregnant or breast feeding

- Concurrent or prior history of cancer other than adequately treated non-melanoma skin
cancer or carcinoma in situ of the cervix

- Allergy to contrast media that would preclude angiography of the hepatic arteries