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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00530010 |
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 how well 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 |
Drug: yttrium Y 90 glass microspheres |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma |
Estimated Enrollment: | 500 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of intrahepatic carcinoma
No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any of the following contraindications to angiography and selective visceral catheterization:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Study Chair: | Riad Salem, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Riad Salem ) |
Study ID Numbers: | CDR0000564718, NU-1365-001 |
Study First Received: | September 13, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00530010 |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms Methamphetamine |
Digestive System Diseases Gastrointestinal Neoplasms Amphetamine Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |