Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer

Summary

NEONAX is an interventional, prospective, randomized, controlled, open label, two sided survival phase II studies against a fixed survival probability, with an unconnected analysis of the results in both experimental arms. Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post randomization

Timeline

Start

2015-07

Primary completion

2021-04

Completion

2022-10

Outcome

Missed primary endpoint

paper The primary endpoint, DFS rate of 55% at 18 months (mITT population), was not reached in either arm of the trial PMID 36209981 ↗

Publications

• Seufferlein T, Uhl W, Kornmann M, Algul H, Friess H, Konig A, Ghadimi M, Gallmeier E, Bartsch DK, Lutz MP, Metzger R, Wille K, Gerdes B, Schimanski CC, Graupe F, Kunzmann V, Klein I, Geissler M, Staib L, Waldschmidt D, Bruns C, Wittel U, Fichtner-Feigl S, Daum S, Hinke A, Blome L, Tannapfel A, Kleger A, Berger AW, Kestler AMR, Schuhbaur JS, Perkhofer L, Tempero M, Reinacher-Schick AC, Ettrich TJ. Perioperative or only adjuvant gemcitabine plus nab-paclitaxel for resectable pancreatic cancer (NEONAX)-a randomized phase II trial of the AIO pancreatic cancer group. Ann Oncol. 2023 Jan;34(1):91-100. doi: 10.1016/j.annonc.2022.09.161. Epub 2022 Oct 7.
• Ettrich TJ, Berger AW, Perkhofer L, Daum S, Konig A, Dickhut A, Wittel U, Wille K, Geissler M, Algul H, Gallmeier E, Atzpodien J, Kornmann M, Muche R, Prasnikar N, Tannapfel A, Reinacher-Schick A, Uhl W, Seufferlein T. 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. BMC Cancer. 2018 Dec 29;18(1):1298. doi: 10.1186/s12885-018-5183-y.

Drugs

Indications