NEONAX: Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer—A phase II study of the AIO Pancreatic Cancer Group.

Authors

Thomas Ettrich

Thomas Jens Ettrich

Ulm University Hospital, Ulm, Germany

Thomas Jens Ettrich , Andreas W. Berger , Rainer Muche , Manfred P. Lutz , Nicole Prasnikar , Waldemar Uhl , Andrea Tannapfel , Volker Heinemann , Thomas Seufferlein

Organizations

Ulm University Hospital, Ulm, Germany, Department of Internal Medicine I, University of Ulm, Ulm, Germany, Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany, Caritasklinik St. Theresa, Saarbruecken, Germany, Klinikum Ludwigsburg, Ludwigsburg, Germany, St. Josef-Hospital, Bochum, Germany, Department of Pathology, Ruhr-University Bochum, Bochum, Germany, Department of Hematology and Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, LMU Munich, Munich, Germany

Research Funding

Pharmaceutical/Biotech Company

Background: 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. Methods: NEONAX is a study for patients (to be enrolled: n=162) 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 II/2014 in 20 high-volume centers for pancreatic surgery in Germany. Clinical trial information: NCT02047513.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Pancreatic Cancer

Clinical Trial Registration Number

NCT02047513

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4158)

DOI

10.1200/jco.2014.32.15_suppl.tps4158

Abstract #

TPS4158

Poster Bd #

238A

Abstract Disclosures