NCT02125136: NEOLAP

Prospective Randomized Multicenter Phase II Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

Completed Phase 2 Last updated 14 December 2021

What this trial tests

Phase 2 trial testing Gem/nab-Pac in Ductal Adenocarcinoma of the Pancreas in 168 participants. Completed in 19 February 2020.

Timeline

1 November 2014

Primary endpoint
1 March 2019

19 February 2020

Quick facts

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	1 November 2014
Primary completion	1 March 2019
Estimated completion	19 February 2020
Sites	1 location across Germany

Drugs / interventions tested

• Gem/nab-Pac — full drug profile →
• FOLFIFINOX — full drug profile →

Conditions studied

• Ductal Adenocarcinoma of the Pancreas — all drugs for Ductal Adenocarcinoma of the Pancreas →

Sponsor

AIO-Studien-gGmbH — full company profile →

Who can join

Adults 18 to 75, any sex, with Ductal Adenocarcinoma of the Pancreas. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Conversion Rate
  Time frame: approx. 10 month
  To compare the effect of intensified neoadjuvant chemotherapy on conversion rate to resectability in LAPC.

Sponsor's own description

The aim ot the study is to investigate the efficacy and safety of two new intensified chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and consecutive conversion of the tumor to resectability.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pancreatic Ductal Adenocarcinoma: Current and Evolving Therapies.
   Adamska A, Domenichini A, Falasca M. · · 2017 · cited 429× · PMID 28640192 · DOI 10.3390/ijms18071338
2. Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
   Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
3. Nab-paclitaxel plus gemcitabine versus nab-paclitaxel plus gemcitabine followed by FOLFIRINOX induction chemotherapy in locally advanced pancreatic cancer (NEOLAP-AIO-PAK-0113): a multicentre, randomised, phase 2 trial.
   Kunzmann V, Siveke JT, Algül H, Goekkurt E, et al · · 2021 · cited 144× · PMID 33338442 · DOI 10.1016/s2468-1253(20)30330-7
4. Recent advances in chemotherapy for pancreatic cancer: evidence from Japan and recommendations in guidelines.
   Okusaka T, Furuse J. · · 2020 · cited 69× · PMID 31997007 · DOI 10.1007/s00535-020-01666-y
5. Nano albumin bound-paclitaxel in pancreatic cancer: Current evidences and future directions.
   Giordano G, Pancione M, Olivieri N, Parcesepe P, et al · · 2017 · cited 67× · PMID 28932079 · DOI 10.3748/wjg.v23.i32.5875
6. Locally Advanced Pancreatic Cancer: Work-Up, Staging, and Local Intervention Strategies.
   van Veldhuisen E, van den Oord C, Brada LJ, Walma MS, et al · · 2019 · cited 62× · PMID 31336859 · DOI 10.3390/cancers11070976
7. Consensus, debate, and prospective on pancreatic cancer treatments.
   Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
8. Recent advances in the treatment of pancreatic cancer.
   Roth MT, Cardin DB, Berlin JD. · · 2020 · cited 49× · PMID 32148767 · DOI 10.12688/f1000research.21981.1