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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: quality-of-life assessment
* Radiation: yttrium Y 90 resin microspheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIR-SPHERES<br> | Procedure: quality-of-life assessment<br>* quality-of-life assessment<br>Radiation: yttrium Y 90 resin microspheres<br>* radiation therapy<br>* Other names: radiation therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, advanced adult primary liver cancer