# NEONAX

Source: https://onco.cc/trials/neonax/  
OnCo record `neonax` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

NEONAX compared giving gemcitabine and nab-paclitaxel around surgery with giving it only afterwards; neither arm reached the trial's 55 percent target for being relapse-free at 18 months, but patients treated before surgery lived a median 25.5 months against 16.7, mostly because so few in the surgery-first arm were ever fit enough to start chemotherapy.

## Summary

NEONAX randomised 127 patients 1 to 1 to perioperative (arm A) or adjuvant-only (arm B) gemcitabine 1,000 mg/m2 with nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 of 28-day cycles. The pre-defined 18-month disease-free survival rate of 55 percent was reached in neither arm (A 33.3 percent, 95 percent confidence interval 18.5 to 48.1; B 41.4 percent, 20.7 to 62.0, in the modified intention-to-treat population of resected patients who started their allocated chemotherapy). Ninety percent of arm A completed neoadjuvant treatment while only 42 percent of arm B started adjuvant chemotherapy; R0 resection was 88 against 67 percent. In the full intention-to-treat population median overall survival was 25.5 months (19.7 to 29.7) in the perioperative arm against 16.7 months (11.6 to 22.2) with upfront surgery, and median disease-free survival 11.5 against 5.9 months. The authors called neoadjuvant treatment a novel option whose regimen remains to be defined; the corpus cites the trial beside NORPACT-1 and SWOG S1505 as the phase 2 evidence that frames Alliance A021806 and PREOPANC-3.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Also known as: AIO-PAK-0313
- Registry id: NCT02047513
- Phase: 2
- Setting: Resectable pancreatic ductal adenocarcinoma at 22 German centres: two cycles of gemcitabine plus nab-paclitaxel before surgery and four after, against six adjuvant cycles after upfront surgery, with 18-month disease-free survival as the primary endpoint in each arm
- Sponsor: AIO-Studien-gGmbH (German pancreatic cancer group), with Celgene
- Enrolled: 127
- Result: 18-month disease-free survival 33.3 percent (perioperative) and 41.4 percent (adjuvant), both below the 55 percent target; median overall survival 25.5 against 16.7 months in the intention-to-treat population.
- Outcomes: Disease-free survival at 18 months (modified intention to treat): Perioperative gemcitabine + nab-paclitaxel 33.3% vs Adjuvant gemcitabine + nab-paclitaxel after upfront surgery 41.4%; Overall survival (intention to treat): Perioperative gemcitabine + nab-paclitaxel 25.5 months vs Adjuvant gemcitabine + nab-paclitaxel after upfront surgery 16.7 months

## Sources

- ClinicalTrials.gov NCT02047513: https://clinicaltrials.gov/study/NCT02047513
- Seufferlein et al., NEONAX (Annals of Oncology 2023): https://doi.org/10.1016/j.annonc.2022.09.161

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/)
- companies: [AIO (Arbeitsgemeinschaft Internistische Onkologie)](https://onco.cc/companies/aio/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [NORPACT-1](https://onco.cc/trials/norpact-1/)

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