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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589030 |
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying the side effects and how well yttrium Y 90 radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Liver Cancer |
Radiation: brachytherapy Radiation: yttrium Y 90 glass microspheres |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yittrium-90 Glass Microspheres): A HDE Treatment Use Protocol |
Estimated Enrollment: | 50 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.
After completion of study therapy, patients are followed for 30 days and then every 3 months for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed* diagnosis of hepatocellular carcinoma (HCC)
No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
PATIENT CHARACTERISTICS:
None of the following contraindications to angiography and selective visceral catheterization allowed:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Yi-Jen Chen, MD, PhD 800-826-4673 YiChen@coh.org |
Principal Investigator: | Yi-Jen Chen, MD, PhD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Yi-Jen Chen ) |
Study ID Numbers: | CDR0000579146, CHNMC-06057 |
Study First Received: | January 3, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00589030 History of Changes |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Recurrence Carcinoma Liver Neoplasms Methamphetamine |
Digestive System Diseases Gastrointestinal Neoplasms Amphetamine Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |