Trial name or title	FOLFOX plus SIR‐Spheres microspheres versus FOLFOX alone in patients with liver metastases from primary colorectal cancer (SIRFLOX)
Methods	Multicentre RCT, phase III
Participants	Estimated enrolment 318
Interventions	FOLFOX (Oxaliplatin 85mg/m2, leucovorin 200mg/m2, fluorouracil 400mg/m2 bolus, fluorouracil 2.4g/m2 infusion) intravenously every 2 weeks vs. FOLFOX (with oxaliplatin 60mg/m2 for the first 3 cycles then 85mg/m2 for subsequent cycles) + SIR‐Sphere implanted on the 3rd or 4th day of the first cycle
Outcomes	Progression free survival, overall survival, response rate, quality of life, liver resection rate, toxicity and safety
Starting date	August 2006
Contact information	mtapner@sirtex.com
Notes	Patients will be stratified for presence of extra‐hepatic disease. A maximum of 40% of enrolled patients will have extra‐hepatic disease