TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01349075
Recruitment Status : Recruiting
First Posted : May 6, 2011
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
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 or disease Intervention/treatment
Hepatocellular Carcinoma Radiation: TheraSphere

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
Study Start Date : October 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Response to Treatment [ Time Frame: Through 24 months post-treatment ]
    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 :
  1. Safety [ Time Frame: Through 24 months post-treatment or death ]
    Evaluate toxicities and adverse experiences associated with TheraSphere treatment

  2. Survival Time [ Time Frame: Through 24 months post-treatment or death ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01349075

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

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: David Eschelman, MD         
Sub-Investigator: Carin Gonsalves, MD         
Sub-Investigator: Voichita Bar-Ad, MD         
Principal Investigator: Colette Shaw, MD         
Sub-Investigator: Susan Shamimi Noori, MD         
Sub-Investigator: Ashwin Sama, MD         
Sub-Investigator: Mark Hurwitz, MD         
Sub-Investigator: Jesse Civan, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator: Colette Shaw, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT01349075     History of Changes
Other Study ID Numbers: 07D.366
2007-49 ( Other Identifier: CCRRC )
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Hepatocellular Carcinoma

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