internal radiation therapy in treating patients with primary liver cancer that cannot be removed by surgery

Conditions: Liver Cancer

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.

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.

Eligibility criteria:
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

Keywords: adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer recurrent adult primary liver cancer advanced adult primary liver cancer