Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With 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 yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.
Radiation: yttrium Y 90 glass microspheres
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol|
- Access to treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
- Patient experience associated with treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: Yes ]
- Liver database [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
- Tumor response rate [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (radiation therapy)
Patients receive yttrium Y 90 glass microspheres via hepatic arterial infusion. Beginning 4-12 weeks later, some patients may receive additional treatment courses.
The target dose of TheraSphere® is 80-150GyRadiation: yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150Gy
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Enter treatment experience into a liver database.
- Determine the tumor response rates in patients receiving this treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.
After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Yi-Jen Chen, MD, PhD||City of Hope Medical Center|