TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
ClinicalTrials.gov Identifier:
NCT00683631
First received: May 16, 2008
Last updated: October 18, 2013
Last verified: October 2013
  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:


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 ]

Enrollment: 150
Study Start Date: January 2004
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TheraSphere
TheraSphere
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
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

Locations
United States, Kentucky
University of Louisville Hospital / Norton Hospital
Louisville, Kentucky, United States, 40202
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: Robert C. Martin, Professor of Surgery, 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: October 18, 2013
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, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 22, 2014