Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial

作者：for the Dutch Pancreatic Cancer Group (DPCG), Eva Versteijne, Casper H.J. van Eijck, Cornelis J.A. Punt, Mustafa Suker, Aeilko Having Zwinderman, Miriam A. C. Dohmen, Karin Groothuis, Oliver R. C. Busch, Marc G. Besselink, Ignace H. J. T. de Hingh, Albert J. ten Tije, Gijs A. Patijn, Bert A. Bonsing, Judith de Vos‐Geelen, Joost M. Klaase, Sebastiaan Festen, Djamila Boerma, Joris I. Erdmann, Izaak Quintus Molenaar, Erwin van der Harst, Marion B.M. van der Kolk, Coen R. N. Rasch, Geertjan van Tienhoven · 发表于：Trials · 年份：2016 · DOI：10.1186/s13063-016-1262-z · 被引用次数：157 · 研究领域：Pancreatic and Hepatic Oncology Research、Renal cell carcinoma treatment、Pancreatitis Pathology and Treatment

BACKGROUND: Pancreatic cancer is the fourth largest cause of cancer death in the United States and Europe with over 100,000 deaths per year in Europe alone. The overall 5-year survival ranges from 2-7 % and has hardly improved over the last two decades. Approximately 15 % of all patients have resectable disease at diagnosis, and of those, only a subgroup has a resectable tumour at surgical exploration. Data from cohort studies have suggested that outcome can be improved by preoperative radiochemotherapy, but data from well-designed randomized studies are lacking. Our PREOPANC phase III trial aims to test the hypothesis that median overall survival of patients with resectable or borderline resectable pancreatic cancer can be improved with preoperative radiochemotherapy. METHODS/DESIGN: The PREOPANC trial is a randomized, controlled, multicentric superiority trial, initiated by the Dutch Pancreatic Cancer Group. Patients with (borderline) resectable pancreatic cancer are randomized to A: direct explorative laparotomy or B: after negative diagnostic laparoscopy, preoperative radiochemotherapy, followed by explorative laparotomy. A hypofractionated radiation scheme of 15 fractions of 2.4 gray (Gy) is combined with a course of gemcitabine, 1,000 mg/m(2)/dose on days 1, 8 and 15, preceded and followed by a modified course of gemcitabine. The target volumes of radiation are delineated on a 4D CT scan, where at least 95 % of the prescribed dose of 36 Gy in 15 fractions should cover 9...