Spots Global Cancer Trial Database for Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

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Trial Identification

Brief Title: Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Official Title: The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma

Study ID: NCT00039078

Conditions

Liver Cancer

Interventions

yttrium Y 90 glass microspheres

Study Description

Brief Summary: RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: * Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma. * Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres. * Determine the toxic effects and adverse experiences associated with this therapy in these patients. * Determine the survival time of patients treated with this therapy. * Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy. * Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy. * Assess the quality of life of patients treated with this therapy. OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time. Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.