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

Vanderbilt University Medical Center

Status

Terminated

Conditions

Liver Cancer

Treatments

Radiation: yttrium Y 90 resin microspheres

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00469963

VU-VICC-GI-0364

VICC GI 0364

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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