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

NCT ID: NCT00469963

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-04-30

Brief Summary

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.

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; advanced adult primary liver cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIR-SPHERES

Group Type: EXPERIMENTAL

quality-of-life assessment

Intervention Type: PROCEDURE

quality-of-life assessment

yttrium Y 90 resin microspheres

Intervention Type: RADIATION

radiation therapy

Interventions

quality-of-life assessment

quality-of-life assessment

Intervention Type: PROCEDURE

yttrium Y 90 resin microspheres

radiation therapy

Intervention Type: RADIATION

Other Intervention Names

radiation therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Meranze, MD

Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven G. Meranze, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VU-VICC-GI-0364

Identifier Type: -

Identifier Source: secondary_id

VICC GI 0364

Identifier Type: -

Identifier Source: org_study_id