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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Meranze, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00469963
First received: May 3, 2007
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

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

PRIOR CONCURRENT THERAPY:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469963

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
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
ClinicalTrials.gov 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:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014