The FOXFIRE and FOXFIRE Global Studies
FOXFIRE and FOXFIRE Global are randomized controlled clinical studies comparing SIR-Spheres® Y-90 resin microspheres in combination with standard-of care chemotherapy versus chemotherapy alone in first-line treatment of metastatic colorectal cancer (mCRC).
Both studies recruited chemotherapy-naïve patients with non-resectable liver metastases from primary colorectal cancer, with or without limited extra-hepatic disease.
FOXFIRE study design:
FOXFIRE Global study design:
The FOXFIRE study recruited >360 patients from the UK and the FOXFIRE Global study recruited >200 patients globally. The study designs of FOXFIRE, FOXFIRE Global and SIRFLOX are similar and the primary endpoint of Overall Survival will be assessed in a combined analysis of all three studies. The analysis will include data from >1,100 patients and is expected to be released in 2017.
Secondary endpoints of the FOXFIRE and FOXFIRE Global studies include Progression-Free Survival (PFS), PFS in the Liver, Safety and Toxicity, Healthcare Costs/Health Economics, Health-Related Quality of Life, Response Rate, Liver Resection Rate and the interval to and proportion of patients receiving second-line treatment.