Two Sequential Randomized Phase Ii Trials of Combination Chemotherapy With Methotrexate/5-Fluorouracil and Cisplatin/5-Fluorouracil for Advanced Pancreatic Cancer

Abstract

Aim:Two sequential studies were performed to examine the effect of combination chemotherapy for patients with preoperative TNM stage III/IV advanced pancreatic cancer. Methods:In the first study, a randomized Phase II trial, comparing intraoperative radiation therapy (IORT) to IORT plus combination chemotherapy of methotrexate (MTX) and 5-fuluorouracil (5-FU) was performed. Based on the results of the first trial, a second randomized trial combination therapy comparing MTX plus 5-FU to that of cisplatin (CDDP) plus 5-FU was performed. Results:Thirty-three patients were entered into the first study. The second study was conducted sequentially and enrolled 27 patients. In the first study, overall survival and