Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors

Phase 2

Terminated

• Conditions: Pheochromocytoma; Head and Neck Cancer; Islet Cell Tumor; Metastatic Cancer
• Interventions: Drug: octreotide acetate; Radiation: yttrium Y 90 resin microspheres

• Registration Number: NCT00466856
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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 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.

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2006-10
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Study Completion: 2007-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sir-Spheres	octreotide acetate	-
Sir-Spheres	yttrium Y 90 resin microspheres	-

Primary Outcome Measures

Name	Time	Method
Tumor response	at 1 year or until intervening death

Secondary Outcome Measures

Name	Time	Method
Toxicity as measured by CTC v3.0	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	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)	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.

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States