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

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Trial Identification

Brief Title: Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Official Title: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Study ID: NCT00530010

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 how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: * Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection. * Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment. OUTLINE: This is a humanitarian device exemption use study. Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.