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