Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
- Conditions
- Liver Cancer
- Registration Number
- NCT00039078
- Lead Sponsor
- Allan Tsung
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to treatment Survival time from treatment Adverse experiences
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Liver Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States