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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00469963
• Other study ID #: VICC GI 0364
• Secondary ID: VU-VICC-GI-0364
• Status: Terminated
• Phase: N/A
• First received: May 3, 2007
• Last updated: August 31, 2012
• Start date: December 2003
• Est. completion date: April 2007

Study information

• Verified date: August 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• quality-of-life assessment
quality-of-life assessment

Radiation:
• yttrium Y 90 resin microspheres
radiation therapy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Toxicity		up to 3 months	Yes
Secondary	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.	No
Secondary	Survival		trial entry to death	No