Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
- Conditions
- Liver Cancer
- Interventions
- Procedure: quality-of-life assessmentRadiation: yttrium Y 90 resin microspheres
- Registration Number
- NCT00469963
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SIR-SPHERES quality-of-life assessment - SIR-SPHERES yttrium Y 90 resin microspheres -
- Primary Outcome Measures
Name Time Method Tumor response up to 12 months 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
Name Time Method Toxicity up to 3 months Health-related quality of life prior to initial treatment. 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 trial entry to death
Trial Locations
- Locations (1)
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States