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Brief Title: Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Official Title: Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
Study ID: NCT00466856
Brief Summary: RATIONALE: Specialized 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 phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.
Detailed Description: OBJECTIVES: Primary * Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroendocrine tumors. Secondary * Determine the toxicity of this treatment in these patients. * Determine the symptomatic relief of patients treated with this regimen. * Determine the health-related quality of life of patients receiving this treatment. OUTLINE: Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) via the catheter on day 1. Patients also receive octreotide acetate IV 1 hour prior to, during, and 2 hours after Sir-Spheres® injection. Patients may undergo above treatment in another lobe of the liver (if each lobe is treated separately) 4 weeks later. Patients undergo functional performance, health-related quality of life, and symptom severity assessment prior to initial treatment and after completion of study treatment. After completion of study treatment, patients are followed periodically for at least 1 year. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Name: Steven G. Meranze, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: PRINCIPAL_INVESTIGATOR