A RANDOMIZED TRIAL OF INTRAOPERATIVE RADIATION-THERAPY (IORT) VS IORT PLUS CHEMOTHERAPY (MTX-5FU) FOR ADENOCARCINOMA OF THE PANCREAS

Between January 1989 and April 1991, 33 pancreatic cancer patients with preoperative cTNM Stage III or IV were randomized to receive either IORT (33Gy) (arm A) or IORT plus chemotherapy (MTX-5FU) (arm B). Fifteen patients in arm A and 17 in arm B remained for this analysis; one patient initially randomized into arm A was excluded due to diagnosis of islet cell carcinoma. The two arms were well balanced for the prognostic variables. No complications due to IORT were recognized in any of the patients. The toxicities of MTX-5FU in arm B were modest. In arm A, the survival rates at 6 months and 1 year were 27% and 13%, respectively; and, in arm B, 76% and 35%, respectively. The hospital-free survival rates at 6 months and 1 year were 27% and 0%, respectively, in arm A; and 65% and 35%, respectively, in arm B. Both the survival and the hospital-free survival rates were significantly higher in arm B than in arm A. The median survivals were 4.8 months in arm A and 8.5 months in arm B. The median hospital-free survivals were 1.6 months in arm A and 7.5 months in arm B. These results indicate that IORT plus MTX-5FU is safe and beneficial f or patients with advanced pancreatic cancer.