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

Between January 1989 and April 1991, 33 pancreatic cancer patients wit h preoperative cTNM Stage III or IV were randomized to receive either IORT (33Gy) (arm A) or IORT plus chemotherapy (MTX-5FU) (arm B). Fifte en patients in arm A and 17 in arm B remained for this analysis; one p atient initially randomized into arm A was excluded due to diagnosis o f islet cell carcinoma. The two arms were well balanced for the progno stic 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%, respect ively; and, in arm B, 76% and 35%, respectively. The hospital-free sur vival rates at 6 months and 1 year were 27% and 0%, respectively, in a rm A; and 65% and 35%, respectively, in arm B. Both the survival and t he hospital-free survival rates were significantly higher in arm B tha n in arm A. The median survivals were 4.8 months in arm A and 8.5 mont hs 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 canc er.