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news.Sirtex has launched an international clinical study evaluating the safety and efficacy of Sir-Spheres1 microspheres when administered with Folfox6 as a first line therapy in patients with non-resectable colorectal liver metastases compared to chemotherapy alone.
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The Sirflox study, which will take place at 25-35 sites in Australia, the US, EU and New Zealand, is the largest of its kind. It will involve 318 patients, with progression-free survival as the primary endpoint. The trial will be conducted in the US under an FDA-approved protocol via an investigational device exemption.
Sirtex Medical’s Sir-Spheres microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial Fudr chemotherapy.
Samuel Putnam, medical director of US operations at Sirtex, said: “Our goal is that by combining SIR-Spheres microspheres with Folfox6 much earlier in the treatment process, we will document an improvement in survival time and patient quality of life.”