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

Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: quality-of-life assessment; Radiation: yttrium Y 90 resin microspheres

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIR-SPHERES	Procedure: quality-of-life assessment; quality-of-life assessment; Radiation: yttrium Y 90 resin microspheres; radiation therapy; Other Names: radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	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.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity		up to 3 months
Health-related quality of life	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.	prior to initial treatment.
Survival		trial entry to death

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: advanced adult primary liver cancer; recurrent adult primary liver cancer; localized unresectable adult primary liver cancer; adult primary hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: VICC GI 0364; VU-VICC-GI-0364