Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma|
- Response to treatment
- Survival time from treatment
- Adverse experiences
|Study Start Date:||August 2000|
|Estimated Study Completion Date:||August 2000|
|Estimated Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
- Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
- Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
- Determine the toxic effects and adverse experiences associated with this therapy in these patients.
- Determine the survival time of patients treated with this therapy.
- Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
- Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
- Assess the quality of life of patients treated with this therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039078
|United States, Pennsylvania|
|UPMC Liver Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||T. Clark Gamblin, MD||UPMC Cancer Center at UPMC Presbyterian|