P-0126 - Neonax: Neoadjuvant plus adjuvant or only adjuvant nab-Paclitaxel plus gemcitabine for resectable pancreatic cancer: A phase II study of the AIO pan...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Thomas Ettrich
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors T. Ettrich1, A. Berger2, R. Muche3, M. Lutz4, N. Prasnikar5, W. Uhl6, A. Tannapfel7, V. Heinemann8, T. Seufferlein2
  • 1Department Of Internal Medicine I, University of Ulm, Ulm/DE
  • 2Department of Internal Medicine I, University of Ulm, Ulm/DE
  • 3Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm/DE
  • 4Caritasklinik St. Theresa, Saarbruecken/DE
  • 5Klinikum Ludwigsburg, Ludwigsburg/DE
  • 6Department of Surgery, Ruhr University Bochum, Bochum/DE
  • 7Department of Pathology, Ruhr-University Bochum, Bochum/DE
  • 8Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Munich/DE



Resectable pancreatic cancer still has an unfavourable prognosis. Neoadjuvant or perioperative therapies might improve the prognosis of these patients. Recently, two phase III trials demonstrated for the first time, a substantial improvement in overall response, PFS and OS in patients with metastatic pancreatic cancer compared to standard gemcitabine (FOLFIRINOX and nab-paclitaxel/gemcitabine). The combination of nab-paclitaxel/gemcitabine has a more favourable toxicity profile compared to the FOLFIRINOX protocol and appears applicable in a perioperative setting.


NEONAX is a study for patients (to be enrolled: n = 166) with resectable ductal adenocarcinoma of the pancreas ≤ T3 in two arms: Arm A (perioperative arm): 2 cycles nab-paclitaxel (125 mg/m2)/gemcitabine (1000 mg/m2, d1, 8 and 15 of an 28 day-cycle) – tumor surgery – 4 cycles nab-paclitaxel/gemcitabine, Arm B (adjuvant only arm): tumor surgery – 6 cycles nab-paclitaxel/gemcitabine. NEONAX is an interventional, prospective, randomized, controlled, open label, two sided phase II study with an unconnected analysis of the results in both experimental arms against a fixed survival probability (38% at 18 month with adjuvant gemcitabine). The randomization (1:1) is eminent to achieve two comparable patient groups. Primary objective is DFS at 18 months after randomization. Key secondary objectives are 3-year OS and DFS, progression during neoadjuvant therapy and QoL. In the perioperative group tumor tissue will be collected prior to and post-surgery and subjected to microdissection and exome sequencing of tumor tissue. Tumor regression will be assessed both in the perioperative and the adjuvant group, respectively. In addition, circulating tumor-DNA will be analyzed in patients with the best and the worst responses to the neoadjuvant treatment.


Start of trial will be in III/2014 in 20 high-volume centers for pancreatic surgery in Germany. (Trial identifier: NCT02047513).