Spots Global Cancer Trial Database for Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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Trial Identification

Brief Title: Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Study ID: NCT00589030

Conditions

Liver Cancer

Interventions

brachytherapy

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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: Primary * Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates. * Evaluate patient experience and toxicities associated with TheraSphere® treatment. * Enter treatment experience into a liver database. Secondary * Determine the tumor response rates in patients receiving this treatment. OUTLINE: This is a humanitarian device exemption use study. Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion. After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.