Phase III trial of irradiation plus chemotherapy for patients with hepatic metastases and hepatoma: experience of the Northern California Oncology Group.

The effects of iv or intra-arterial chemotherapy added to hepatic irradiation were evaluated in a 3-arm randomized trial. Patients with predominantly hepatic metastases or with hepatoma were eligible. They were randomized to receive 2,100 cGy in seven fractions alone or with 5-fluorouracil given either intra-arterially or by iv infusion; doxorubicin and mitomycin were given by bolus simultaneously with the radiation in a single course. A total of 166 patients were entered in the study. Toxicity was acceptable, with no sign of enhanced radiation damage. Response was evaluated 4-6 weeks after treatment. No complete responses were seen, but partial responses greater than or equal to 50% were observed in the groups treated with radiation only (17%), radiation plus drug given iv (25%), and radiation plus drug given intra-arterially (20%) (P greater than .3). Disease progression occurred in a larger number of patients who received radiation only (29%) at 6 weeks than in the other 2 groups (7% and 18%, respectively; P less than .03). Thus, in terms of local response duration, the addition of chemotherapy enhanced the effect of the radiation. Survival was not different among the 3 groups.

RCT Entities:   Population Interventions Outcomes