Heinrich et al. BMC Cancer 2011, 11:346 http://www.biomedcentral.com/1471-2407/11/346 Eligibility criteria Patients (> 18 years) with resectable cytologically proven adenocarcinoma of the pancreatic head without general contraindications for a pancreatico-duodenectomy are eligible for this study (table 1). All patients have to pro- vide written informed consent. Tumors with portal vein infiltration of more than 180°, tumor abutment of major visceral arteries (T4) or distant metastases (M1) are excluded from this study (Figure 2). A previous percutaneous biopsy of the pri- mary tumor is considered an exclusion criterion as well as a chronic neuropathy or WHO performance status > °2. Also, women of childbearing age not using adequate contraception as well as pregnant and lactating women are excluded. Furthermore, mental or organic disorders which interfere with the informed consent or the treat- ment are considered exclusion criteria. Finally, a second malignancy diagnosed within the past 5 years, except for non-melanomatous skin cancer or non-invasive cervical cancer. Staging examinations Before study inclusion, distant metastases are ruled out by contrast-enhanced (ce)CT scan of chest and abdo- men. Furthermore, all patients require a diagnostic laparoscopy to exclude peritoneal or small hepatic metastases. If positron-emission tomography (PET)/CT is available, centers may decide to use PET/CT for sta- ging and restaging in all patients. Local resectability is also determined by ceCT. Fine needle aspiration cytol- ogy (FNA) by endoscopic ultrasound or brush cytology Table 1 Eligibility criteria for the NEOPAC trial. Inclusion criteria resectable adenocarcinoma of the pancreatic head - T1-3, Nx, M0 (UICC 6th version, 2002) cytologic or histologic confirmation of adenocarcinoma age > 18 years written informed consent Page 3 of 7 by endoscopic retrograde cholangio-pancreatography (ERCP) is required to confirm pancreatic cancer prior to study inclusion. ceCT (or PET/CT) as well as diagnostic laparoscopy are repeated after neoadjuvant chemotherapy in order to exclude unresectability due to disease progression. Chemotherapy Neoadjuvant chemotherapy consists of 4 bi-weekly cycles of gemcitabine (1000 mg/m2) and oxaliplatin (100 mg/m2). After pancreas resection, all patients receive, adjuvant chemotherapy with 6 cycles of gemcitabine 1000 mg/m2 (d1, d8, d15). Side-effects of chemotherapy are graded by the “Common Terminology Criteria for Adverse Events” version 3 http://ctep.cancer.gov/forms/CTCAEv3.pdf. At each study visit, laboratory parameters are determined for dose adjustments. Surgery Surgery must be performed within 10-20 days after the last neoadjuvant GemOx infusion or as soon as possi- ble in the control arm. Resection of the pancreatic head will be preferentially performed as a standard pancreaticoduodenectomy. Alternatively, pylorus-pre- serving resections or other reconstructions can be performed. Surgical morbidity is assessed by the Dindo/Clavien classification [16]. Pancreatic fistula are defined by the definition of the international study group for pancreatic surgery (ISGPS) [17]. Exclusion criteria contraindication for duodenopancreatectomy distant metastases infiltration > 180° of the portal vein abutment of the tumor to the SMA infiltration of the SMA or the celiac trunk chronic neuropathy > grade 2 WHO performance score > 2 uncorrectable cholestasis (bilirubin > 100 mmol/l despite drainage attempts for more than four weeks prior to inclusion) female patients in child bearing age not using adequate contraception pregnant or lactating women mental or organic disorders which could interfere with informed consent or treatments Second malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer percutaneous tumor biopsy