Heinrich et al. BMC Cancer 2011, 11:346 http://www.biomedcentral.com/1471-2407/11/346 dedicated pathologist to confirm the diagnosis of ductal adenocarcinoma (A.W.). Translational research The quality of life (QoL) will be assessed by the QLQ-30 of the European Organization for Research and Treat- ment of Cancer (EORTC) at study inclusion, before (neoadjuvant arm) and after surgery, as well as at any follow-up visit. In addition, the histological response of the tumor to the neoadjuvant treatment will be assessed by established scores [11]. Tumor tissue will be stored to enable further translation research and assess poten- tial predictive factors. Discussion Adjuvant chemotherapy is considered a standard treat- ment after a curative resection of pancreatic cancer in many centers due to the improvements in disease-free and overall survival. However, a significant proportion of patients does not receive this treatment postopera- tively due to the morbidity of pancreas surgery. Neoadjuvant treatments are established concepts for rectal and gastric cancer [18,19], where the toxicity is bet- ter tolerated [19]. Furthermore, neoadjuvant treatments can be applied to almost all patients independent of the surgical morbidity, and helps improving the nutritional status in malnourished pancreatic cancer patients [11]. Very recently, the FOLFIRINOX regimen has been reported to be superior to a Gem-mono treatment in the palliative treatment of pancreatic cancer [20]. This treatment achieved a higher objective response rate (31.6% versus 9.4%), less quality of life impairment (31% versus 66%) and a better median progression-free survi- val (6.4 versus 3.3 months). However, FOLFIRINOX is more toxic than Gem-mono with grade III/IV neutrope- nia and diarrhea of 45% versus 21% and 12.7% versus 1.8%, respectively [20]. In contrast, the combination of gemcitabine and platin derivates is also more effective than Gem-mono treatment, but has minimal side-effects [21]. Therefore, the safety of this combination as neoad- juvant chemotherapy has been evaluated in a phase II- trial. In this trial, neoadjuvant treatment was safe and well tolerated [13]. The objective of the NEOPAC study is to determine for the first time the efficacy of this short-term neoadju- vant chemotherapy in addition to the current standard treatment. Based on the results of a phase II-trial, we hypothesize that the postoperative course of the pan- creaticoduodenectomy will be less complicated following neoadjuvant chemotherapy due to the improvement of the nutritional status [13]. Therefore, these patients will presumably receive adjuvant chemotherapy to a higher percentage, which should result in a better long-term survival. Page 6 of 7 Since the NEOPAC trial tests neoadjuvant chemother- apy in primarily resectable disease, and not a down-siz- ing protocol, local resectability criteria are very strict, and the staging and re-staging protocols are extensive. Furthermore, this study will reveal the percentage of patients eligible for adjuvant chemotherapy after surgery and provide the median survival of the entire cohort of patients with resectable cancer of the pancreatic head. In addition to these clinical questions, this study design offers a unique potential for translational research projects. This study is a multicenter study, and recruitment has started. Any center with appropriate case load and logis- tics (e.g. EUS) interested in participating in this study is welcome to contact the principle investigator (PAC) for further information. List of abbreviations Bd: Bile duct; ceCT: contrast-enhanced computed tomography; Cis: Cisplatin; CONKO: Charité Onkologie; ERCP: endoscopic retrograde cholangio- pancretaography; ESPAC: European study group for pancreatic cancer; EUS: endoscopic ultrasound; FNA: fine-needle aspiration; PET/CT: positron- emission-tomography/computed tomography; Gem: Gemcitabine; Ox: Oxaliplatin; QoL: Quality of life; QLQ-30: Quality-of-life-questionnaire 30; SMA: superior mesenteric artery; SMV: superior mesenteric vein. Acknowledgements Until submission of this manuscript. this study is supported by the Swiss National Foundation (32003B_135802), the Sasella Foundation (CH), the “Stiftung zur Krebsbekämpfung Zürich” (CH), Sanofi-Aventis (CH), TEVA Pharma (CH). Author details 1Department of General and Abdominal Surgery, University Hospital of Mainz, Langenbeck-strasse 1, 55118 Mainz, Germany. 2Department of Medical Oncology, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland. 3Visceral and Transplantation Surgery, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland. 4Department of General and Hepatobiliary Surgery University Hospital of Ghent, De Pintelaan 185, B-9000 Ghent, Belgium. 5Department of Gastroenterology, Digestive Oncology, University Hospital of Ghent, De Pintelaan 185, B-9000 Ghent, Belgium. 6Department of Surgery, Institut Pauli Calmettes, 232 Bd Ste Marguerite, 13273 Marseille, France. 7Department of Oncology, Institut Pauli Calmettes, 232 Bd Ste Marguerite, 13273 Marseille, France. 8Department of Visceral Surgery, University Hospital of Strasbourg, Hôpital Hautepierre, Avenue Molière, 67098 Strasbourg, France. 9Department of Oncology, University Hospital of Strasbourg, Hôpital Hautepierre, Avenue Molière, 67098 Strasbourg, France. 10Department of Internal Medicine, Gastroenterology/ Gastrointestinal Oncology, University Hospital of Mainz, Langenbeckstrasse 1, 55118 Mainz, Germany. 11Department of Pathology, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland. Authors’ contributions SH and BP designed the study and participate in the performance and coordination of the trial. ML, PB, KG, JRD, JLR, PB, PD, MM, HL and XR participate in the trial performance and patient recruitment. AW is the reference pathologist for confirmation of histological diagnosis and assessment of histological response, and PAC is the principle investigator. All authors have read and approved the final manuscript. Competing interests The authors declare that they have no competing interests. Received: 31 May 2011 Accepted: 10 August 2011 Published: 10 August 2011