This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
PRIMARY OBJECTIVES: I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
299
Given via catheter
M D Anderson Cancer Center
Houston, Texas, United States
Oversight to treatment with yttrium Y 90 glass microspheres
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Time frame: Up to 2 years
Patient experience
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Time frame: Up to 2 years
Incidence of adverse events
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Time frame: 30 days after each treatment
Overall survival
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Time frame: Up to 2 years
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