Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
- Determine tumor response to selective internal radiation therapy with yttrium Y 90
resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 1 year or until intervening death
Steven G. Meranze, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0365
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|