Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
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.
|Liver Cancer||Procedure: quality-of-life assessment Radiation: yttrium Y 90 resin microspheres|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma|
- Tumor response [ Time Frame: up to 12 months ]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.
- Toxicity [ Time Frame: up to 3 months ]
- Health-related quality of life [ Time Frame: prior to initial treatment. ]
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.
- Survival [ Time Frame: trial entry to death ]
|Study Start Date:||December 2003|
|Study Completion Date:||April 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Procedure: quality-of-life assessment
quality-of-life assessmentRadiation: yttrium Y 90 resin microspheres
Other Name: radiation therapy
- Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular carcinoma.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469963
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Steven G. Meranze, MD||Vanderbilt-Ingram Cancer Center|