The median radiation dose delivered was 60.75 Gy (1.5-Gy fractions bid). The study design provided more than 80% power to detect a two-fold increase in median survival compared with historical controls at a 5% significance level. The radiation dose was based on a normal-tissue complication probability model and subjected the patient to an estimated maximum risk of radiation-induced liver disease of 10% to 15%. Three-dimensional conformal high-dose radiation therapy was delivered concurrently with hepatic arterial floxuridine in 128 patients. A phase II trial was conducted to determine if high-dose radiation with concurrent hepatic arterial floxuridine would improve survival in patients with unresectable intrahepatic malignancies.
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