TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01349075
First received: May 4, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Radiation: TheraSphere

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 85
Study Start Date: October 2007
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TheraSphere Radiation: TheraSphere
The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.
Other Name: Yttrium-90

Detailed Description:

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.

  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 hepatocellular carcinoma of the liver
  • Patients who are able to give informed consent, will be eligible.
  • Patients must have an ECOG Performance Status score of < or = 2
  • Must have a life expectancy of > 3 months
  • Non-pregnant with an acceptable contraception in premenopausal women
  • Patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment of radiation to the lungs
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnancy
  • Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
  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: NCT01349075

Contacts
Contact: Colette Shaw, MD 215-955-8619
Contact: Radiation Oncology Clinical Research 215-955-8619

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Colette Shaw, MD    215-955-8619      
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         
Sub-Investigator: Nancy Lewis, MD         
Principal Investigator: Colette Shaw, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Colette Shaw, MD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01349075     History of Changes
Other Study ID Numbers: 07D.366, 2007-49
Study First Received: May 4, 2011
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Unresectable
Hepatocellular Carcinoma
TheraSphere
Yttrium-90

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 September 18, 2014