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A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

Liver Cancer Clinical Trial

Official title:
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Clinical Trial Summary

Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Clinical Trial Description

Protocol Objectives include:

- Determine the proportion of patients with HCC in whom the treatment plan can be completed

- Evaluate the response to therapy

- Evaluate toxicities and adverse experiences associated with TheraSphere treatment

- Evaluate survival time ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00152087
Study type Interventional
Source St. Joseph's Hospital, Florida
Contact Mary Pritchard, RN, OCN
Phone 813-870-4257
Email Mary.Pritchard@baycare.org
Status Recruiting
Phase Phase 2
Start date October 2002
Completion date June 2005
View Details
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