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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466856
Recruitment Status : Terminated (due to slow accrual)
First Posted : April 27, 2007
Last Update Posted : May 18, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Meranze, MD, 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.

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Sir-Spheres Drug: octreotide acetate

Lung/liver Ratio Dose of SIR-Spheres

  • <10% Administer full dose of SIR-Spheres
  • 10% to 15% Reduce dose of SIR-Spheres by 20%
  • 16% to 20% Reduce dose of SIR-Spheres by 40%
  • >20% Do not give SIR-Spheres
Other Name: octreotide

Radiation: yttrium Y 90 resin microspheres
Other Name: octreotide

Primary Outcome Measures :
  1. Tumor response [ Time Frame: at 1 year or until intervening death ]

Secondary Outcome Measures :
  1. Toxicity as measured by CTC v3.0 [ Time Frame: at 1 year or until intervening death ]
  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Pathologically confirmed neuroendocrine tumor metastatic to the liver

    • Well-differentiated or moderately well-differentiated neuroendocrine tumors
  • 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:

      • Moderate-severe right upper quadrant pain and unintentional weight loss > 10%
      • Decline in Karnofsky performance status > 10 points
  • 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


  • Karnofsky performance status 50-100%
  • Life expectancy ≥ 6 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin ≥ 3.0 g/dL
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 65,000/mm³
  • Hemoglobin > 9.0 g/dL
  • INR ≤ 1.4
  • No hepatic arterial anatomy that would preclude the administration of study treatment into the liver
  • No nonmalignant disease that would preclude study participation
  • No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix


  • Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed
  • No prior radiotherapy to the upper abdomen that includes the liver in the treatment field
  • No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks
  • No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00466856

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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
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Responsible Party: Steven Meranze, MD, Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00466856    
Other Study ID Numbers: VICC GI 0365
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012
Keywords provided by Steven Meranze, MD, Vanderbilt-Ingram Cancer Center:
neoplastic syndrome
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
thyroid gland medullary carcinoma
metastatic pheochromocytoma
recurrent islet cell carcinoma
liver metastases
recurrent pheochromocytoma
WDHA syndrome
pancreatic polypeptide tumor
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Adenoma, Islet Cell
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents