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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Lung/liver Ratio Dose of SIR-Spheres * \<10% Administer full dose of SIR-Spheres * 10% to 15% Reduce dose of SIR-Spheres by 20% * 16% to 20% Reduce dose of SIR-Spheres by 40% * \>20% Do not give SIR-Spheres
radiation
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Tumor response
Time frame: at 1 year or until intervening death
Toxicity as measured by CTC v3.0
Time frame: at 1 year or until intervening death
Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.
Time frame: at 1 year or until intervening death
Patient report of Health-related quality of life (HRQOL)
HRQOL will be determined via the Medical Outcome Study 36-item short form, which includeds 8 individual scales, physical and mental component summary scores and is normed to both health and clinical populations.
Time frame: at 1 year or until intervening death
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