Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00039078|
Recruitment Status : Withdrawn (Record created in error - not a research study)
First Posted : January 27, 2003
Last Update Posted : June 26, 2017
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 or disease||Intervention/treatment||Phase|
|Liver Cancer||Radiation: yttrium Y 90 glass microspheres||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma|
|Study Start Date :||August 2000|
|Primary Completion Date :||August 2000|
|Study Completion Date :||August 2000|
- Response to treatment
- Survival time from treatment
- Adverse experiences
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): 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|