SIMULTANEOUS HIGH-DOSE EXTERNAL IRRADIATION AND DAILY CISPLATIN IN UNRESECTABLE, NONMETASTATIC ADENOCARCINOMA OF THE PANCREAS - A PHASE I-II STUDY

Background and purpose: Clinical trials have demonstrated that high do se radiation therapy and daily cisplatin (CDDP) could increase local c ontrol and survival in carcinoma from various sites. The present phase I-II study has combined high dose radiation therapy and daily CDDP at escalating dosages. Methods: From August 1994 to December 1995, 23 pa tients with non-resectable carcinoma of the pancreas were enrolled in a phase I-II multicentric, pilot study to test the toxicity and the ef fectiveness of high dose radiotherapy and daily cisplatin (CDDP) at es calating dosages. A dose of 6 mg/sqm/day of CDDP was selected for the phase II step since no grade IV toxicity occurred in any patient in th e phase I step. Results: Toxicity was considered fairly acceptable. At the time of analysis, the 23 patients who entered the study had clear evidence of evolutive disease either locally or distantly in the live r. It is suggested that high dose radiotherapy (60 Gy continuously) an d daily CDDP have little effect on local control of the tumor and surv ival, and only a moderate effect on pain. Conclusions: In unresectable , apparently non-metastatic cancers of the pancreas, there is an urgen t need for new agents or new combinations of agents to be rested. (C) 1997 Elsevier Science Ireland Ltd.