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BMC Cancer. 2018 Dec 29;18(1):1298. doi: 10.1186/s12885-018-5183-y.

Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group.

Author information

1
Department of Internal Medicine I, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
2
Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité University Medicine Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
3
Department of Gastroenterology and Gastrointestinal Oncology, University Medical Center Goettingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany.
4
Department of Oncology/Hematology, Fulda Hospital, Pacelliallee 4, 36043, Fulda, Germany.
5
Department of General and Visceral Surgery, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.
6
Department of Hematology and medical oncology, Johannes-Wesling-Klinikum Minden, Hans-Nolte-Straße 1, 32429, Minden, Germany.
7
Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Esslingen Hospital, Hirschlandstr. 97, 73730 Esslingen, Esslingen, Germany.
8
Department of Internal Medicine II, Technical University Munich, Ismaninger Str. 22, 81675, Munich, Germany.
9
Department of Gastroenterology and Endocrinology, University of Marburg, Baldingerstraße, 35043, Marburg, Germany.
10
Department of Medical Oncology and Hematology, Niels-Stensen-Kliniken, Alte Rothenfelder Str. 23, 49124, Georgsmarienhütte, Germany.
11
Department of General and Visceral Surgery, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
12
Institute of Epidemiology and Medical Biometry, University of Ulm, Schwabstrasse 13, 89081, Ulm, Germany.
13
Department of Oncologie, Asklepios Klinik Barmbek, Rübenkamp 220, 22291, Hamburg, Germany.
14
Department of Pathology, Ruhr-University Bochum, Bürkle-de-la-Camp-Platz 1, 44789, Bochum, Germany.
15
Department of Internal Medicine, Ruhr-University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
16
Department of Surgery, Ruhr-University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
17
Department of Internal Medicine I, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. thomas.seufferlein@uniklinik-ulm.de.

Abstract

BACKGROUND:

Even clearly resectable pancreatic cancer still has an unfavorable prognosis. Neoadjuvant or perioperative therapies might improve the prognosis of these patients. Thus, evaluation of perioperative chemotherapy in resectable pancreatic cancer in a prospective, randomized trial is warranted. A substantial improvement in overall survival of patients with metastatic pancreatic cancer with FOLFIRINOX and nab-paclitaxel/gemcitabine vs standard gemcitabine has been demonstrated in phase III-trials. Indeed nab-paclitaxel/gemcitabine has a more favorable toxicity profile compared to the FOLFIRINOX protocol and appears applicable in a perioperative setting.

METHODS:

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 months with adjuvant gemcitabine), NCT02047513. NEONAX will enroll 166 patients with resectable pancreatic ductal adenocarcinoma (≤ cT3, N0 or N1, cM0) 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) followed by tumor surgery followed by 4 cycles nab-paclitaxel/gemcitabine, Arm B (adjuvant arm): tumor surgery followed by 6 cycles nab-paclitaxel/gemcitabine. The randomization (1:1) is eminent to avoid allocation bias between the groups. Randomization is stratified for tumor stage (ct1/2 vs. cT3) and lymph node status (cN0 vs. cN1). Primary objective is disease free survival (DFS) at 18 months after randomization. Key secondary objectives are 3-year overall survival (OS) rate and DFS rate, progression during neoadjuvant therapy, R0 and R1 resection rate, quality of life and correlation of DFS, OS and tumor regression with pharmacogenomic markers, tumor biomarkers and molecular analyses (ctDNA, transcriptome, miRNA-arrays). In addition, circulating tumor-DNA will be analyzed in patients with the best and the worst responses to the neoadjuvant treatment. The study was initiated in March 2015 in 26 centers for pancreatic surgery in Germany.

DISCUSSION:

The NEONAX trial is an innovative study on resectable pancreatic cancer and currently one of the largest trials in this field of research. It addresses the question of the role of intensified perioperative treatment with nab-paclitaxel plus gemcitabine in resectable pancreatic cancers to improve disease-free survival and offers a unique potential for translational research.

TRIAL REGISTRATION:

ClinicalTrials.gov : NCT02047513, 08/13/2014.

KEYWORDS:

Neoadjuvant chemotherapy; Pancreatic cancer; Pancreatic ductal adenocarcinoma; Perioperative chemotherapy; Resectable

PMID:
30594153
PMCID:
PMC6311014
DOI:
10.1186/s12885-018-5183-y
[Indexed for MEDLINE]
Free PMC Article

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