The primary purpose is to evaluate survival without disease progression in 150 patients with metastatic disease to the liver following treatment with TheraSpheres. Survival without disease progression will be assessed by imaging using MRI or CT scans. We will also evaluate safety of TheraSphere when used to treat patients with metastatic disease to the liver.
Protocol number: J0660
Type of cancer: Stage IV Colorectal Cancer
Phase number: II
Summary: TheraSphere is a device that consists of a tiny glass beads that are embedded with a radioactive agent (yttrium-90 or Y-90). TheraSphere is delivered to the liver tumor(s) through a catheter placed by an interventional radiologist at the femoral artery (at the top of the thigh) and fed into the hepatic artery, which supplies blood to the liver tumor(s). Once placed in the liver, the TheraSphere remain there and deliver radiation to the liver tumor(s) for a period of approximately 2 weeks. One or both lobes of the liver may be treated with TheraSphere. TheraSphere is generally an outpatient procedure and if more than one lobe is treated this is done during a second procedure.