NCT00469963

Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
PROCEDURE	quality-of-life assessment	quality-of-life assessment
RADIATION	yttrium Y 90 resin microspheres	radiation therapy

Timeline

• Start date: 2003-12-01
• Primary completion: 2006-10-01
• Completion: 2007-04-01
• First posted: 2007-05-07
• Last updated: 2012-09-03

Locations

1 site across 1 country: United States