Liver Cancer Clinical Trial
Official title:
Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma
RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation
directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well internal radiation therapy works in
treating patients with primary liver cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- Determine tumor response to selective internal radiation therapy comprising yttrium Y
90 resin microspheres (Sir-Spheres®) in patients with unresectable primary
hepatocellular carcinoma.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the health-related quality of life of patients receiving this regimen.
- Determine the survival of patients receiving this regimen.
OUTLINE: Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin
microspheres (Sir-Spheres®) via catheter directly into the hepatic artery on day 1.
Health-related quality of life is assessed prior to initial treatment and then periodically
thereafter.
After completion of study treatment, patients are followed periodically for 12-24 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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