A phase II multi-institutional study to evaluate gemcitabine and fractionated stereotactic body radiotherapy for unresectable, locally advanced pancreatic adenocarcinoma.

4045 Background: Phase I/II studies with single-fraction (25 Gy) stereotactic body radiotherapy (SBRT) for pancreatic ductal adenocarcinoma (PDA) have shown local progression free survival (LPFS) rates of >90%, but are limited by late GI toxicity and minimal tumor response. We performed a phase II multi-center trial of gemcitabine (GEM) and fractionated SBRT to determine if a high rate of LPFS with reduced toxicity could be achieved. Methods: After multidisciplinary review, 32 pts with locally advanced PDA received GEM in sequence with SBRT (6.6 Gy in 5 consecutive daily fractions, 33 Gy total). LPFS, metastasis free survival (MFS), and overall survival (OS) were measured from date of tissue diagnosis. Objective tumor response (OTR) was assessed by RECIST/PERCIST. EORTC QLQ-C30/PAN26 questionnaires were used to measure QOL. Results: Median f-up was 12 mos (range, 2-23). Mean age was 69.9 yrs (SD, 9.8) and 62% were male. Pts received a mean of 2.2 (SD, 1.0) GEM doses prior to SBRT and 8.3 (SD, 5.6) doses t...