Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

This study has been terminated.
(slow accrual)
Information provided by (Responsible Party):
Steven Meranze, MD, Vanderbilt-Ingram Cancer Center Identifier:
First received: May 3, 2007
Last updated: August 31, 2012
Last verified: August 2012

RATIONALE: Specialized internal 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 clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.

Condition Intervention
Liver Cancer
Procedure: quality-of-life assessment
Radiation: yttrium Y 90 resin microspheres

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Tumor response [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    All uni-dimensional measurable lesions (longest diameter >20mm with conventional techniques and >10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.

Secondary Outcome Measures:
  • Toxicity [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
  • Health-related quality of life [ Time Frame: prior to initial treatment. ] [ Designated as safety issue: No ]

    The assessment will include a Karnofsky score the patient-completed SF-36 questionnaire. This information will be assessed at each quarterly evaluation, as well as any unscheduled clinical appointments. Karnofsky functional performance36 will be assessed by a clinician. This widely-used scale ranges from 0 to 100 and derives three broad categories of functional performance (able: 80-100; unable: 50-70; and disabled: 0-40).

    Patient report of HRQOL will be determined via the Medical Outcome Study 36-item short form (SF-36)37, which includes eight individual scales, physical and mental component summary scores, and is normed to both healthy and clinical populations.

  • Survival [ Time Frame: trial entry to death ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2003
Study Completion Date: April 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIR-SPHERES Procedure: quality-of-life assessment
quality-of-life assessment
Other Name: quality-of-life assessment
Radiation: yttrium Y 90 resin microspheres
radiation therapy
Other Name: radiation therapy

Detailed Description:



  • Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular carcinoma.


  • Determine the toxicity of this regimen in these patients.
  • Determine the health-related quality of life of patients receiving this regimen.
  • Determine the survival of patients receiving this regimen.

OUTLINE: Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) via catheter directly into the hepatic artery on day 1.

Health-related quality of life is assessed prior to initial treatment and then periodically thereafter.

After completion of study treatment, patients are followed periodically for 12-24 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma

    • Not amenable to surgical resection or immediate liver transplantation

      • Destaging of tumor prior to surgical resection or transplantation allowed
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan

    • No equivocal, nonmeasurable, or nonevaluable liver cancer
  • No more than 75% replacement of normal liver by tumor
  • Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
  • No extra-hepatic metastases as determined by CT scan or MRI

Exclusion Criteria:

  • Life expectancy ≥ 3 months
  • Karnofsky performance status 50-100%
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin ≥ 3 g/dL
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 65,000/mm³
  • INR ≤ 1.4
  • Hemoglobin > 9 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
  • No hepatic arterial anatomy that would prevent the administration of study drug into the liver
  • Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
  • 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


  • See Disease Characteristics
  • More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
  • More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
  • No prior radiotherapy to the upper abdomen that included the liver in the treatment field
  • No capecitabine within 8 weeks before or after study treatment
  • No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatment
  Contacts and Locations
Please refer to this study by its identifier: NCT00469963

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Principal Investigator: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

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: NCT00469963     History of Changes
Other Study ID Numbers: VICC GI 0364, VU-VICC-GI-0364
Study First Received: May 3, 2007
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
advanced adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on April 15, 2014