TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)
The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TheraSphere HUD For Treatment of Unresectable HCC|
- Tumor Response after treatment [ Time Frame: Review all standard of care CT scans to evaluate tumor response after treatment ] [ Designated as safety issue: Yes ]
- Incidence of toxicities / Adverse Events [ Time Frame: Monitor for toxicities to Therasphere ] [ Designated as safety issue: Yes ]
- Evaluate survival time [ Time Frame: life long ] [ Designated as safety issue: Yes ]
- Determine proportion of patients with HCC that can be treated with Therasphere [ Time Frame: at screening ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Radiation: TheraSphere HUD
TheraSphere is FDA approved under a Humanitarian Use Device. It is considered a brachytherapy device that delivers intra-arterial radiation therapy using yttrium-90 microspheres directly to liver tumors.
Other Name: TheraSphere HDE # 980006
Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
|United States, Kentucky|
|University of Louisville Hospital / Norton Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Robert C. Martin, MD||University of Louisville|