TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel. This allows a large local dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma|
- Response to Treatment [ Time Frame: Through 24 months post-treatment ] [ Designated as safety issue: No ]Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.
- Safety [ Time Frame: Through 24 months post-treatment or death ] [ Designated as safety issue: Yes ]Evaluate toxicities and adverse experiences associated with TheraSphere treatment
- Survival Time [ Time Frame: Through 24 months post-treatment or death ] [ Designated as safety issue: No ]Evaluate survival time from the first treatment. The disease status, survival and safety status of all patients who receive TheraSphere treatment will be evaluated annually until death or 2 years post-treatment. In general, follow-up will be performed by the principal clinician. In the event of patient death, the date and cause of death will be recorded in the medical record (if possible).
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.
Other Name: Yttrium-90
Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.
|Contact: Susan Littman, MD||215-955-8874|
|Contact: Radiation Oncology Clinical Research||215-955-8619|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Nancy Lewis, MD 215-955-8874|
|Contact: Radiation Oncology Clinical Research 215-955-8619|
|Sub-Investigator: Pramila Rani Anne, MD|
|Sub-Investigator: Charles Intenzo, MD|
|Sub-Investigator: Daniel Brown, MD|
|Sub-Investigator: David Eschelman, MD|
|Sub-Investigator: Carin Gonsalves, MD|
|Sub-Investigator: Adam Dicker, MD, PhD|
|Sub-Investigator: Maria Werner-Wasik, MD|
|Sub-Investigator: Wenyin Shi, MD|
|Sub-Investigator: Voichita Bar-Ad, MD|
|Sub-Investigator: Jeffrey McCann, MD|
|Principal Investigator: Nancy Lewis, MD|
|Principal Investigator:||Susan Littman, MD||Thomas Jefferson University|