Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
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.
Head and Neck Cancer
Islet Cell Tumor
Drug: octreotide acetate
Radiation: yttrium Y 90 resin microspheres
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors|
- Tumor response [ Time Frame: at 1 year or until intervening death ] [ Designated as safety issue: No ]
- Toxicity as measured by CTC v3.0 [ Time Frame: at 1 year or until intervening death ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2003|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Drug: octreotide acetate
Lung/liver Ratio Dose of SIR-Spheres
Other Name: octreotideRadiation: yttrium Y 90 resin microspheres
Other Name: octreotide
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466856
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Steven G. Meranze, MD||Vanderbilt-Ingram Cancer Center|