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Table 3 Inclusion criteria

From: Primary resection versus neoadjuvant chemoradiation followed by resection for locally resectable or potentially resectable pancreatic carcinoma without distant metastasis. A multi-centre prospectively randomised phase II-study of the Interdisciplinary Working Group Gastrointestinal Tumours (AIO, ARO, and CAO)

• Histologically proven ductal adenocarcinoma of the pancreatic head (tumours of the pancreatic head right to the left edge of the superior mesenteric vein including the uncinate process), stage I- IV A according to UICC 1997. Histological proof should be performed via percutaneous CT- or ultrasound guided biopsy (up to 3 attempts) if impossible by endoscopic biopsy or endoscopic cytology (brush cytology with tumour cells).

• No infiltration of extrapancreatic organs with the exception of the duodenum

• pancreatic tumour as imaged in multi slice spiral CT (slice collimation 3 mm) estimated to be resectable or probably resectable by an experienced surgeon on the base of the following criteria: vascular involvement ≤ 180° of one of the peripancreatic major vessels (portal vein, confluent of superior mesenteric vein and, splenic vein, superior mesenteric artery, celiac trunk with its major branches splenic artery and hepatic artery, superior mesenteric vein) (Lu et al., 1997).

• maximally 1 enlarged (> 1 cm) regional lymph node in thin slice spiral CT, without signs of vessel infiltration

• no distant metastasis (in X-ray chest, abdominal CT and laparoscopy)

• no peritoneal spread (laparoscopy prior to randomization is recommended)

• age at treatment initiation minimally 18 years

• Karnofsky performance status ≥ 70 (70 – not capable to work, independent)

• Written informed consent of the patient