Journal Article

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

Dajani, Olav F., Koenig, Ute, Besselink, Marc G., Braren, Rickmer, Liffers, Sven Thorsten, Pelzer, Uwe, Nordin, Arno, Bratlie, Svein Olav, Labori, Knut Jørgen, Wilmink, Hanneke, Uijterwijk, Bas, Friede, Tim, Antweiler, Kai, Seppanen, Hanna, Johansson, Mia, Crede, Marie, Ghadimi, Michael, Puolakkainen, Pauli, Telgmann, Ralph, Siveke, Jens, Jo, Peter, Koenig, Alexander

2025

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Ablation / Ablation (Surgery) / Adenocarcinoma / administration & dosage / Adult / Aged / Angina pectoris / Antineoplastic Combined Chemotherapy Protocols / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Biomarkers / Biomedical and Life Sciences / Biomedicine / Cancer / Cancer Research / Cancer therapies / Carcinoma / Carcinoma, Pancreatic Ductal - pathology / Carcinoma, Pancreatic Ductal - secondary / Carcinoma, Pancreatic Ductal - surgery / Carcinoma, Pancreatic Ductal - therapy / Care and treatment / Chemotherapy / Clinical significance / Clinical Trials / Clinical Trials, Phase III as Topic / Combined Modality Therapy / drug therapy / Female / Fluorouracil / Health aspects / Health Promotion and Disease Prevention / Humans / Induction therapy / Irinotecan / Kirurgi / Leucovorin / Liver / Liver cancer / Liver diseases / Liver metastasis / Liver Neoplasms / Liver Neoplasms - drug therapy / Liver Neoplasms - secondary / Liver Neoplasms - surgery / Liver Neoplasms - therapy / Male / Medicine/Public Health / Metastases / Metastasis / Middle Aged / Mortality / Multicenter Studies as Topic / Multimodal treatment / Oligometastasis / Oligometastatic pancreatic cancer / Oncology / Oxaliplatin / Pancreatectomy / Pancreatic cancer / Pancreatic Ductal / Pancreatic ductal carcinoma (PDAC) / Pancreatic Neoplasms / Pancreatic Neoplasms - drug therapy / Pancreatic Neoplasms - mortality / Pancreatic Neoplasms - pathology / Pancreatic Neoplasms - surgery / Pancreatic Neoplasms - therapy / pathology / Patient outcomes / Patients / Phase III as Topic / Quality of life / Randomized Controlled Trials as Topic / secondary / Study Protocol / Surgery / Surgical Oncology / Survival / therapeutic use / therapy / Tumors