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Sponsored by: |
UPMC Cancer Centers |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039078 |
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 of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Radiation: yttrium Y 90 glass microspheres |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma |
Estimated Enrollment: | 500 |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.
Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
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)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Pennsylvania | |
UPMC Liver Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Clinical Trials Office - UPMC Liver Cancer Center 412-692-2001 |
Study Chair: | T. Clark Gamblin, MD | UPMC Cancer Center at UPMC Presbyterian |
Study ID Numbers: | CDR0000069336, PCI-IRB-0611014, PCI-IRB-000656, PCI-IRB-000871, NCI-V02-1701 |
Study First Received: | June 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00039078 History of Changes |
Health Authority: | Unspecified |
localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
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 |