Liver Cancer
Conditions
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, advanced adult primary liver cancer
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.
Interventions
PROCEDUREquality-of-life assessment
quality-of-life assessment
RADIATIONyttrium Y 90 resin microspheres
radiation therapy
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed