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
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 af...
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2025-02-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Michael Ghadimi |
| collection | DOAJ |
| description | 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. |
| format | Article |
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| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-02-01 |
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| spelling | doaj-art-d5d766bd0b564ed9927e21bb8a6e31ad2025-02-09T12:41:41ZengBMCBMC Cancer1471-24072025-02-0125111210.1186/s12885-025-13573-7Study 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 trialMichael Ghadimi0Uwe Pelzer1Marc G. Besselink2Jens Siveke3Ralph Telgmann4Rickmer Braren5Hanneke Wilmink6Marie Crede7Alexander Koenig8Ute Koenig9Sven Thorsten Liffers10Kai Antweiler11Bas Uijterwijk12Hanna Seppanen13Arno Nordin14Pauli Puolakkainen15Olav F. Dajani16Knut Jørgen Labori17Mia Johansson18Svein Olav Bratlie19Tim Friede20Peter Jo21Department of General, Visceral and Pediatric Surgery, University Medical Center GoettingenDivision of Oncology and Hematology, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of HealthDepartment of Surgery, Amsterdam UMC, University of AmsterdamUniversity Hospital Essen, West German Cancer CenterClinical Trials Unit, University Medical Center GoettingenInstitute of Diagnostic and Interventional Radiology, Technical University of MunichDepartment of Medical Oncology, Amsterdam UMC, University of AmsterdamDepartment of General, Visceral and Pediatric Surgery, University Medical Center GoettingenDepartment of Gastroenterology and Gastrointestinal Oncology, University Medical Center GoettingenDepartment of Gastroenterology and Gastrointestinal Oncology, University Medical Center GoettingenUniversity Hospital Essen, West German Cancer CenterDepartment of Medical Statistics, University Medical Center GoettingenDepartment of Surgery, Amsterdam UMC, University of AmsterdamDepartment of Gastrointestinal Surgery, University of Helsinki and Helsinki University HospitalDepartment of Gastrointestinal Surgery, University of Helsinki and Helsinki University HospitalDepartment of Abdominal Surgery, University of Helsinki and Helsinki University HospitalDepartment of Oncology, Oslo University HospitalDepartment of Hepato Pancreato Biliary Surgery, Oslo University HospitalDepartment of Oncology, Sahlgrenska University HospitalDepartment of Surgery, Sahlgrenska University HospitalDepartment of Medical Statistics, University Medical Center GoettingenDepartment of General, Visceral and Pediatric Surgery, University Medical Center GoettingenAbstract 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.https://doi.org/10.1186/s12885-025-13573-7OligometastasisPancreatic ductal carcinoma (PDAC)Oligometastatic pancreatic cancerLiver metastasisMultimodal treatmentChemotherapy |
| spellingShingle | 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 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 BMC Cancer Oligometastasis Pancreatic ductal carcinoma (PDAC) Oligometastatic pancreatic cancer Liver metastasis Multimodal treatment Chemotherapy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Oligometastasis Pancreatic ductal carcinoma (PDAC) Oligometastatic pancreatic cancer Liver metastasis Multimodal treatment Chemotherapy |
| url | https://doi.org/10.1186/s12885-025-13573-7 |
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