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. 2025 May 13;25(1):204.
doi: 10.1186/s12893-025-02938-1.

Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol

Luís Filipe Abreu de Carvalho  1 , Filip Gryspeerdt  2 , Wim Ceelen  3 , Karen Geboes  4 , Suzane Ribeiro  5 , Anne Hoorens  6 , Nele Vandenbussche  7   8   9 , Kathleen B M Claes  7   8   9 , Clarisse Lecluyse  10 , Aliaksandr Anisau  10 , Johan Van Ongeval  11 , Willem Lybaert  12 , Lars Triest  13 , Andrew Vervaecke  14 , Steven Sas  15 , Barbara Claerhout  16 , Carolien Beyls  17 , Mark Sie  18 , Frederik Berrevoet  2
Affiliations

Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol

Luís Filipe Abreu de Carvalho et al. BMC Surg. .

Abstract

Background: Neoadjuvant chemotherapy is used in borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC) to increase resection rate and improve cancer outcome. However, there is a need for better prediction of resectability. The aim of this prospective, single arm study is to improve prediction of surgical resection by using radiomics and liquid biopsy.

Methods: In this multicentric trial, 45 patients with BR or LA PADC will undergo neoadjuvant chemotherapy with FOLFIRINOX. An intention to treat analysis will be performed. The primary endpoint is the accuracy of the prediction of surgical resection. Secondary endpoints are overall survival and disease-free survival from the date of diagnosis, R0 and R1 resection rates, histopathological response, postoperative complications, patient reported outcomes with quality of life and health economic analysis. Translational research with multi-omics and radiomics based on computed tomography and magnetic resonance imaging aims to identify factors predictive of surgical resectability and survival. The primary hypothesis is that these strategies can increase the accuracy of predicting surgical resection.

Discussion: Improved prediction of resectability is necessary in BR and LA PDAC. We aim to investigate whether a combination of clinical, radiological, and multi-omics profiling in liquid biopsies can successfully predict resectability and thus optimize the therapeutic decision tree.

Trial registration: ClinicalTrials.gov Identifier: NCT05298722. Date of registration: March 28, 2022.

Keywords: Borderline resectable pancreatic cancer; FOLFIRINOX; Liquid biopsy; Locally advanced pancreatic cancer; Multi-omics; Neoadjuvant chemotherapy; Pancreatic cancer; Precision oncology.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol has been approved by the central Ethics Committee of Ghent University hospital (ONZ-2022-0088; B6702022000402 on 05 December 2022) after consultation with the local Ethics Committees. Protocol version number 3.1; February 25, 2025; Amendment number 2. Any significant change or addition to the protocol will be made in a written protocol amendment that must be approved by the Central Ethics Committee. Trial open for accrual since December 12, 2022. Publication policy: Every attempt will be made to publish the results in peer-reviewed journals. For each topic, the responsible investigator has priority to be mentioned as first or last author, or choose the suitable investigator according to the work involved in the publication. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Clinical flowchart Performance trial. BSC: Best supportive care; WP: Work Package; MDT: Multidisciplinary Team; BR: Borderline resectable pancreatic ductal adenocarcinoma; LA: Locally advanced pancreatic ductal adenocarcinoma; PDAC: Pancreatic ductal adenocarcinoma; CT: Computed Tomography; MRI: Magnetic resonance imaging
Fig. 2
Fig. 2
Flowchart data analysis. WP: Work Package; BR: Borderline resectable pancreatic ductal adenocarcinoma; LA: Locally advanced pancreatic ductal adenocarcinoma; PDAC: Pancreatic ductal adenocarcinoma; BMI: Body mass index; CT: Computed Tomography; MRI: Magnetic resonance imaging; cfDNA: Cell free DNA; cfRNA: Cell free RNA
See this image and copyright information in PMC

References

    1. Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul J-L, et al. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic Cancer. N Engl J Med. 2018;379:2395–406. - PubMed
    1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of pancreatic cancer: global trends, etiology and risk factors. World J Oncol. 2019;10:10–27. - PMC - PubMed
    1. Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73:17–48. - PubMed
    1. National Comprehensive Cancer Network. Pancreatic Adenocarcinoma. (Version 1.2022) https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed 28 Mar 2022.
    1. Marchegiani G, Todaro V, Boninsegna E, Negrelli R, Sureka B, Bonamini D, et al. Surgery after FOLFIRINOX treatment for locally advanced and borderline resectable pancreatic cancer: increase in tumour Attenuation on CT correlates with R0 resection. Eur Radiol. 2018;28:4265–73. - PubMed

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