Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma
- Determine tumor response to selective internal radiation therapy comprising yttrium Y
90 resin microspheres (Sir-Spheres®) in patients with unresectable primary
- 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
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
All uni-dimensional measurable lesions (longest diameter >20mm with conventional techniques and >10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.
up to 12 months
Steven G. Meranze, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0364
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|