Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol
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, si...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s12893-025-02938-1 |
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| author | Luís Filipe Abreu de Carvalho Filip Gryspeerdt Wim Ceelen Karen Geboes Suzane Ribeiro Anne Hoorens Nele Vandenbussche Kathleen B.M. Claes Clarisse Lecluyse Aliaksandr Anisau Johan Van Ongeval Willem Lybaert Lars Triest Andrew Vervaecke Steven Sas Barbara Claerhout Carolien Beyls Mark Sie Frederik Berrevoet |
| author_facet | Luís Filipe Abreu de Carvalho Filip Gryspeerdt Wim Ceelen Karen Geboes Suzane Ribeiro Anne Hoorens Nele Vandenbussche Kathleen B.M. Claes Clarisse Lecluyse Aliaksandr Anisau Johan Van Ongeval Willem Lybaert Lars Triest Andrew Vervaecke Steven Sas Barbara Claerhout Carolien Beyls Mark Sie Frederik Berrevoet |
| author_sort | Luís Filipe Abreu de Carvalho |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c05ecedc7ddb4ea2ae253b5b5d82b2f1 |
| institution | DOAJ |
| issn | 1471-2482 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj-art-c05ecedc7ddb4ea2ae253b5b5d82b2f12025-08-20T03:10:16ZengBMCBMC Surgery1471-24822025-05-012511910.1186/s12893-025-02938-1Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocolLuís Filipe Abreu de Carvalho0Filip Gryspeerdt1Wim Ceelen2Karen Geboes3Suzane Ribeiro4Anne Hoorens5Nele Vandenbussche6Kathleen B.M. Claes7Clarisse Lecluyse8Aliaksandr Anisau9Johan Van Ongeval10Willem Lybaert11Lars Triest12Andrew Vervaecke13Steven Sas14Barbara Claerhout15Carolien Beyls16Mark Sie17Frederik Berrevoet18Department of HPB surgery and liver transplantation, Ghent University HospitalDepartment of HPB surgery and liver transplantation, Ghent University HospitalDepartment of Gastrointestinal surgery, Ghent University HospitalDepartment of Gastroenterology, Division of Digestive Oncology, Ghent University HospitalDepartment of Gastroenterology, Division of Endoscopy and Digestive Oncology, Ghent University HospitalDepartment of Pathology, Ghent University HospitalCenter for Medical Genetics, Ghent University HospitalCenter for Medical Genetics, Ghent University HospitalDepartment of Medical Imaging, Ghent University HospitalDepartment of Medical Imaging, Ghent University HospitalDepartment of Gastroenterology, Division of Digestive Oncology, Ghent Sint-Lucas hospitalDepartment of Gastroenterology, Division of Digestive Oncology, VITAZ hospitalDepartment of Gastroenterology, Division of Digestive Oncology, Sint-Blasius hospitalDepartment of Gastroenterology, Zeno Hospital, Knokke-Heist and BlankenbergeDepartment of Gastroenterology, Division of Digestive Oncology, Jan Palfijn hospitalDepartment of Gastroenterology, Division of Digestive Oncology, Eeklo Hospital AZ ALMADepartment of Gastroenterology, Division of Digestive Oncology, Oudenaarde hospitalDepartment of Medical Oncology, Division of Digestive Oncology, Zorgsaam hospitalDepartment of HPB surgery and liver transplantation, Ghent University HospitalAbstract 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.https://doi.org/10.1186/s12893-025-02938-1Pancreatic cancerBorderline resectable pancreatic cancerLocally advanced pancreatic cancerNeoadjuvant chemotherapyFOLFIRINOXLiquid biopsy |
| spellingShingle | Luís Filipe Abreu de Carvalho Filip Gryspeerdt Wim Ceelen Karen Geboes Suzane Ribeiro Anne Hoorens Nele Vandenbussche Kathleen B.M. Claes Clarisse Lecluyse Aliaksandr Anisau Johan Van Ongeval Willem Lybaert Lars Triest Andrew Vervaecke Steven Sas Barbara Claerhout Carolien Beyls Mark Sie Frederik Berrevoet Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol BMC Surgery Pancreatic cancer Borderline resectable pancreatic cancer Locally advanced pancreatic cancer Neoadjuvant chemotherapy FOLFIRINOX Liquid biopsy |
| title | Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol |
| title_full | Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol |
| title_fullStr | Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol |
| title_full_unstemmed | Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol |
| title_short | Prediction of surgical resectability after FOLFIRINOX chemotherapy for borderline resectable and locally advanced pancreatic cancer (PeRFormanCe): a multicenter prospective trial - trial protocol |
| title_sort | prediction of surgical resectability after folfirinox chemotherapy for borderline resectable and locally advanced pancreatic cancer performance a multicenter prospective trial trial protocol |
| topic | Pancreatic cancer Borderline resectable pancreatic cancer Locally advanced pancreatic cancer Neoadjuvant chemotherapy FOLFIRINOX Liquid biopsy |
| url | https://doi.org/10.1186/s12893-025-02938-1 |
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