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Study Design

FOXFIRE Global is a multi-centre randomised controlled study designed to evaluate the efficacy, in terms of overall survival (OS), 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. The study is designed to allow for a combined analysis with clinical data from the SIRFLOX and FOXFIRE studies. The total sample size in the 3 studies combined will be more than 1000 patients, which provides adequate power to detect a clinical significant difference in Overall Survival between the experimental and control arms.

Patients could recieve, at the investigator's discretion, the biologic agent bevacizumab in addition to the FOLFOX6m chemotherapy regimen. More than 200 patients around the world were randomised in this study. These patients had non-resectable liver metastases from a primary colorectal carcinoma, either with or without evidence of extra-hepatic metastases. Patients should not have received prior chemotherapy for advanced disease. The patients were 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).

FOXFIRE Global schema

The FOXFIRE Global study is being conducted in study sites in Australia, New Zealand, Asia, Europe, the Middle East and the USA. A similar study, the FOXFIRE study is presently being conducted in the UK. The FOXFIRE Global study has been designed so that it may be combined with the SIRFLOX and FOXFIRE studies, allowing for the pooling of the 3 study's data on safety and efficacy outcomes, with the combined studies powered for overall survival. Click here for a link to the SIRFLOX study website.

Study flyer is available to download and print:

 

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