Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Carcinoma, Hepatocellular Clinical Trial

Official title: Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Status Completed

Clinical Trial Summary

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.

The study has the following objectives:

• Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.

• Evaluate patient experience and toxicities associated with TheraSphere treatment

• Evaluate predisposing factors that may influence results and toxicity

Clinical Trial Description

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

1. Range of patients who can be offered TheraSphere®

2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity

3. Survival time

4. Determine response in relation to histology and other parameters

5. Ability to tolerate repeat treatments

6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

• NCT number: NCT00493883
• Study type: Interventional
• Source: Southwestern Regional Medical Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2006
• Completion date: December 2011