TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)
This study has been completed.
MDS Pharma Services
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
First received: May 16, 2008
Last updated: October 18, 2013
Last verified: October 2013
The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.
Radiation: TheraSphere HUD
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||TheraSphere HUD For Treatment of Unresectable HCC
Primary Outcome Measures:
- Tumor Response after treatment [ Time Frame: Review all standard of care CT scans to evaluate tumor response after treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients over 18 years of age, of any race or sex, who have histologic proof of primary cancer to the liver, who are able to give informed consent, will be eligible.
- Patients must have an ECOG Performance Status score of greater than or equal to 2, with a life expectancy of > 3 months, non-pregnant with an acceptable contraception in premenopausal women.
- The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis).
- Participation in the TheraSphere Registry.
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
- Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Refusal to participate in the TheraSphere Registry
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683631
|University of Louisville Hospital / Norton Hospital
|Louisville, Kentucky, United States, 40202 |
University of Louisville
MDS Pharma Services
||Robert C. Martin, MD
||University of Louisville
No publications provided by University of Louisville
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Robert C. Martin, Professor of Surgery, University of Louisville
History of Changes
|Other Study ID Numbers:
||TheraSphere - 421.03
|Study First Received:
||May 16, 2008
||October 18, 2013
||United States: Institutional Review Board
Keywords provided by University of Louisville:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases