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TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.
Verified January 2010 by University of Louisville
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00683631
First received: May 16, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.


Condition Intervention
Hepatocellular Carcinoma
 Radiation: TheraSphere HUD

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by University of Louisville:

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 ]

Estimated Enrollment: 150
Study Start Date: January 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Pregnancy
  • Refusal to participate in the TheraSphere Registry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683631

Contacts
Contact: Susan Ellis 502-629-3384 susan.ellis@louisville.edu

Locations
United States, Kentucky
University of Louisville Hospital / Norton Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Ellis, RN     502-629-3384     susan.ellis@louisville.edu    
Principal Investigator: Robert Martin, MD            
Sub-Investigator: Charles Scoggins, MD            
Sub-Investigator: Kelly McMasters, MD, PhD            
Sponsors and Collaborators
University of Louisville
MDS Pharma Services
Investigators
Principal Investigator: Robert C. Martin, MD University of Louisville
  More Information

No publications provided by University of Louisville

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Robert C. G. Martin, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00683631     History of Changes
Other Study ID Numbers: TheraSphere - 421.03
Study First Received: May 16, 2008
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
liver cancer
liver tumor
HCC
hepatocellular carcinoma
hepatoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013