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Open Access 01-12-2021 | Metastasis | Study protocol

Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)

Authors: Florian Gebauer, Alexander Ioannis Damanakis, Felix Popp, Alexander Quaas, Fabian Kütting, Katrin Lutz, Swantje Held, Burkhard Deuß, Tobias Göser, Dirk Waldschmidt, Christiane Bruns

Published in: BMC Cancer | Issue 1/2021

Abstract

Background

According to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available.

Methods

In this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas.

The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma.

In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection.

Discussion

This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer.

Trial registration numbers

EudraCT 2019–002734-37; NCT04617457.

Available only for authorised users

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Title: Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
Authors: Florian Gebauer
Alexander Ioannis Damanakis
Felix Popp
Alexander Quaas
Fabian Kütting
Katrin Lutz
Swantje Held
Burkhard Deuß
Tobias Göser
Dirk Waldschmidt
Christiane Bruns
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Metastasis
Cytostatic Therapy
Pancreatic Cancer
Pancreatic Cancer
Published in: BMC Cancer / Issue 1/2021
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-021-08966-3

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