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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.
Full description
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.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed neuroendocrine tumor metastatic to the liver
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan
Symptomatic disease, meeting one of the following criteria:
Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale > 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks
Evidence of radiographic progression with either of the following manifestations:
At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months
No more than 75% replacement of normal liver by neuroendocrine tumor
No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan
No equivocal, nonmeasurable, or nonevaluable liver metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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