SIRFLOX clinical trial Selective Internal Radiation Therapy SIR-Spheres treatment liver metastases liver tumour colorectal cancer

SIRFLOX.com

Selective Internal Radiation Therapy using SIR-Spheres

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Study design

SIRFLOX is a multi-centre randomised controlled study  to evaluate the effect of adding targeted radiation, in the form of SIR-Spheres Y-90 resin microspheres, to a standard chemotherapy regimen of FOLFOX6m as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. Patients could also receive at the investigator's discretion the biologic agent bevacizumab in addition to the FOLFOX6m chemotherapy regimen. When enrollment in SIRFLOX was completed in April 2013, more than 500 patients with non-resectable liver metastases from a primary colorectal carcinoma, either with or without evidence of extra-hepatic metastases and who have not received prior chemotherapy for advanced disease, had been randomised to receive either:

a) Treatment Arm A: Systemic chemotherapy consisting of oxaliplatin + leucovorin + 5-fluorouracil (FOLFOX6m), or

b) Treatment Arm B: A single injection of SIR-Spheres Y-90 resin microspheres (or two injections during the same procedure if lobar treatment with SIRT is used) into the liver, plus systemic chemotherapy consisting of oxaliplatin + leucovorin + 5-fluorouracil (FOLFOX6m).

SIRFLOX study Schema

The SIRFLOX study was conducted at study sites in Australia, New Zealand, Europe, the Middle East and the USA. Two similar studies, named FOXFIRE and FOXFIRE Global  have been designed to be combined with the SIRFLOX study, allowing for the pooling of the study's data on safety and efficacy outcomes, with the combined studies powered to demonstrate potential benefit in overall survival. Both studies completed recruitment at the end of 2014, and  results of the combined overall survival analysis are expected during 2017. 

 

 Registered trademark statement

 W005-EUA-0315

About the SIRFLOX study

The SIRFLOX study is an international research study designed to evaluate a new treatment option for patients with colorectal cancer that has undergone metastatic spread to the liver.

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SIRFLOX clinical trial Selective Internal Radiation Therapy SIR-Spheres treatment liver metastases liver tumour colorectal cancer