Heinrich et al. BMC Cancer 2011, 11:346 http://www.biomedcentral.com/1471-2407/11/346 Page 5 of 7 Secondary end-points are the histological response to the neoadjuvant treatment, overall survival, complica- tion rates after surgery, and feasibility of adjuvant chemotherapy. Sample-size calculation Assuming a progression-free survival at one year after randomization of 55% for the neoadjuvant + standard treatment and 40% for the standard treatment, and an equal number of patients in each treatment arm (50/50), a total of 310 patients (155 per arm) are required for this two-arm trial to detect a significant difference with an alpha-error of 0.05 and a 1-b power value of 0.80. Interim analyses are scheduled after inclusion of 100 and 200 patients, and an independent data review board will decide upon continuation of the study. Quality control This study will be performed in compliance with the study protocol, good clinical practice (GCP) and the applicable regulatory requirements. Patient randomization and data collection are per- formed on a central database (secuTrial™), which allows continuous centralized data monitoring of all participat- ing centers. Furthermore, scheduled audits will be per- formed at each study center by the coordinating center in Zurich. Circumferential margins of the resected specimen are stained intraoperatively: dorsal, ventral, mesopancreatic margins as well as the mesenteric groove are stained separately (Figure 3). This will allow exact and reprodu- cible assessment of R0 and R1 resections. Furthermore, a central pathological review will be performed by a Figure 3 Magnetic resonance imaging of the pancreas indicating the circumferential resection margins (bd: bile duct, smv: superior mesenteric vein, arrows indicate pancreatic tail).