Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00466856|
Recruitment Status : Terminated (due to slow accrual)
First Posted : April 27, 2007
Last Update Posted : May 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Islet Cell Tumor Metastatic Cancer Pheochromocytoma||Drug: octreotide acetate Radiation: yttrium Y 90 resin microspheres||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2007|
Drug: octreotide acetate
Lung/liver Ratio Dose of SIR-Spheres
Other Name: octreotideRadiation: yttrium Y 90 resin microspheres
Other Name: octreotide
- 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 [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466856
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Steven G. Meranze, MD||Vanderbilt-Ingram Cancer Center|