Study protocol of the METAPANC trial - intensified treatment in patients with local operable but oligometastatic pancreatic cancer - multimodal surgical treatment versus chemotherapy alone: a randomized controlled trial
Michael Ghadimi,
Uwe Pelzer,
Marc G. Besselink,
Jens Siveke,
Ralph Telgmann,
Rickmer Braren,
Hanneke Wilmink,
Marie Crede,
Alexander Koenig,
Ute Koenig,
Sven Thorsten Liffers,
Kai Antweiler,
Bas Uijterwijk,
Hanna Seppanen,
Arno Nordin,
Pauli Puolakkainen,
Olav F. Dajani,
Knut Jørgen Labori,
Mia Johansson,
Svein Olav Bratlie,
Tim Friede,
Peter Jo
Affiliations
Michael Ghadimi
Department of General, Visceral and Pediatric Surgery, University Medical Center Goettingen
Uwe Pelzer
Division of Oncology and Hematology, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health
Marc G. Besselink
Department of Surgery, Amsterdam UMC, University of Amsterdam
Jens Siveke
University Hospital Essen, West German Cancer Center
Ralph Telgmann
Clinical Trials Unit, University Medical Center Goettingen
Rickmer Braren
Institute of Diagnostic and Interventional Radiology, Technical University of Munich
Hanneke Wilmink
Department of Medical Oncology, Amsterdam UMC, University of Amsterdam
Marie Crede
Department of General, Visceral and Pediatric Surgery, University Medical Center Goettingen
Alexander Koenig
Department of Gastroenterology and Gastrointestinal Oncology, University Medical Center Goettingen
Ute Koenig
Department of Gastroenterology and Gastrointestinal Oncology, University Medical Center Goettingen
Sven Thorsten Liffers
University Hospital Essen, West German Cancer Center
Kai Antweiler
Department of Medical Statistics, University Medical Center Goettingen
Bas Uijterwijk
Department of Surgery, Amsterdam UMC, University of Amsterdam
Hanna Seppanen
Department of Gastrointestinal Surgery, University of Helsinki and Helsinki University Hospital
Arno Nordin
Department of Gastrointestinal Surgery, University of Helsinki and Helsinki University Hospital
Pauli Puolakkainen
Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital
Olav F. Dajani
Department of Oncology, Oslo University Hospital
Knut Jørgen Labori
Department of Hepato Pancreato Biliary Surgery, Oslo University Hospital
Mia Johansson
Department of Oncology, Sahlgrenska University Hospital
Svein Olav Bratlie
Department of Surgery, Sahlgrenska University Hospital
Tim Friede
Department of Medical Statistics, University Medical Center Goettingen
Peter Jo
Department of General, Visceral and Pediatric Surgery, University Medical Center Goettingen
Abstract Background Based on current guidelines, surgical treatment of hepatic oligometastases in patients with pancreatic ductal adenocarcinoma (PDAC) is not primarily recommended. Systematic chemotherapy is the therapy of choice for these patients. The relevance of subsequent surgical resection after chemotherapy remains unclear. This multicentre, randomized, controlled phase III trial is planned to evaluate whether resection of the primary tumor and liver metastases can improve overall survival in patients with PDAC with hepatic oligometastases in a multimodal treatment setting. Methods After an induction therapy with eight cyles of mFOLFIRINOX and a response assessment after four and eight cycles, patients will be randomized to either Arm 1 (perioperative mFOFIRINOX plus resection of the primary tumor with resection or ablation of all hepatic metastases) or Arm 2 (continuation of 4 cycles of the standard-of-care mFOLFIRINOX chemotherapy). This clinical trial will focus on a well-defined patient group with metastatic disease limited to the liver as the target organ, with a maximum of three metastases. Discussion METAPANC is the first international, randomized, controlled, open-label, multicentre, phase III clinical trial for curative intended surgical therapy of oligometastatic pancreatic cancer in Europe and America. The multimodal surgical treatment of patients with oligometastatic pancreatic cancer could significantly extend the overall survival of this patient group. A possible recommendation of this multimodal treatment regimen outside of clinical trials requires data from randomized controlled trials first. To identify patient subgroups that might benefit from multimodal surgical therapy, additional information on tumor genetics could supplement valid parameters. Trial registration EU Clinical Trials No. 2023-503558-10-00.
