TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01349075|
Recruitment Status : Recruiting
First Posted : May 6, 2011
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Radiation: TheraSphere|
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|
|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|
The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.
Other Name: Yttrium-90
- 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.
- Safety [ Time Frame: Through 24 months post-treatment or death ]Evaluate toxicities and adverse experiences associated with TheraSphere treatment
- 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).
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 ClinicalTrials.gov 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|
|Principal Investigator:||Colette Shaw, MD||Thomas Jefferson University|