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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
quality-of-life assessment
radiation therapy
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Tumor response
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.
Time frame: up to 12 months
Toxicity
Time frame: up to 3 months
Health-related quality of life
The assessment will include a Karnofsky score the patient-completed SF-36 questionnaire. This information will be assessed at each quarterly evaluation, as well as any unscheduled clinical appointments. Karnofsky functional performance36 will be assessed by a clinician. This widely-used scale ranges from 0 to 100 and derives three broad categories of functional performance (able: 80-100; unable: 50-70; and disabled: 0-40). Patient report of HRQOL will be determined via the Medical Outcome Study 36-item short form (SF-36)37, which includes eight individual scales, physical and mental component summary scores, and is normed to both healthy and clinical populations.
Time frame: prior to initial treatment.
Survival
Time frame: trial entry to death
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