Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00469963|
Recruitment Status : Terminated (slow accrual)
First Posted : May 7, 2007
Last Update Posted : September 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Procedure: quality-of-life assessment Radiation: yttrium Y 90 resin microspheres||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||April 2007|
Procedure: quality-of-life assessment
Radiation: yttrium Y 90 resin microspheres
Other Name: radiation therapy
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469963
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Steven G. Meranze, MD||Vanderbilt-Ingram Cancer Center|