EVALUATION OF EXTERNAL-BEAM RADIATION-THERAPY PLUS 5-FLUOROURACIL (5-FU) VERSUS EXTERNAL-BEAM RADIATION-THERAPY PLUS HYCANTHONE (HYC) IN CONFINED, UNRESECTABLE PANCREATIC-CANCER

From March 1981 to November 1987, 87 patients with histologically conf irmed pancreatic adenocarcinoma, unresectable but confined to the panc reatic region, were randomized to two treatments. The standard treatme nt was 40-50 Gy external-beam radiation therapy (RT) to gross tumor pl us potential microscopic tumor with a 5 Gy boost to gross tumor plus a 1.5-2.0 cm margin, using multiple fields and 5-fluorouracil (5-FU) 50 0 mg/m(2)/d intravenously by rapid infusion. The 5-FU was given each o f the initial 3 days of each of three 20 Gy radiation courses. The exp erimental treatment used identical radiation fields, but the two Gy da ily radiation fractions were administered in a continuous course to a total dose of 50 Gy. Hycanthone was administered 60 mg/m(2) intravenou sly within 2 to 4 hr during each day of the 5-day course of infusions during the first and fifth weeks of radiation therapy. There was no st atistically significant difference between treatment arms in survival (p = 0.82) or disease-free survival (p = 0.27). Seven percent of hycan thone-treated patients demonstrated hepatic toxicity which was usually mild in nature. There was, however, one death due to hepatic toxicity .