Clinical Trial: Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
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 Summary:
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.
Sponsor: Vanderbilt-Ingram Cancer Center
Current Primary Outcome: Tumor response [ Time Frame: at 1 year or until intervening death ]
Original Primary Outcome:
- Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
- Toxicity as measured by CTC v3.0
- Disease progression
- Health-related quality of life
Current Secondary Outcome:
- 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 [ Time Frame: at 1 year or until intervening death ]The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.
- Patient report of Health-related quality of life (HRQOL) [ Time Frame: at 1 year or until intervening death ]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.
Original Secondary Outcome:
Information By: Vanderbilt-Ingram Cancer Center
Dates:
Date Received: April 25, 2007
Date Started: December 2003
Date Completion:
Last Updated: May 17, 2012
Last Verified: May 2012