Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)

Abstract Background According to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though pr...

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Autores principales:	Florian Gebauer, Alexander Ioannis Damanakis, Felix Popp, Alexander Quaas, Fabian Kütting, Katrin Lutz, Swantje Held, Burkhard Deuß, Tobias Göser, Dirk Waldschmidt, Christiane Bruns
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Chemotherapy Clinical trials Liver metastasis Pancreatic cancer Pancreatic surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/616c088826884c7d99c7984e35c6d4f5
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spelling	oai:doaj.org-article:616c088826884c7d99c7984e35c6d4f52021-11-21T12:30:27ZStudy protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)10.1186/s12885-021-08966-31471-2407https://doaj.org/article/616c088826884c7d99c7984e35c6d4f52021-11-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08966-3https://doaj.org/toc/1471-2407Abstract Background According to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available. Methods In this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas. The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma. In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection. Discussion This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer. Trial registration numbers EudraCT 2019–002734-37 ; NCT04617457 .Florian GebauerAlexander Ioannis DamanakisFelix PoppAlexander QuaasFabian KüttingKatrin LutzSwantje HeldBurkhard DeußTobias GöserDirk WaldschmidtChristiane BrunsBMCarticleChemotherapyClinical trialsLiver metastasisPancreatic cancerPancreatic surgeryNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Chemotherapy Clinical trials Liver metastasis Pancreatic cancer Pancreatic surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Chemotherapy Clinical trials Liver metastasis Pancreatic cancer Pancreatic surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Florian Gebauer Alexander Ioannis Damanakis Felix Popp Alexander Quaas Fabian Kütting Katrin Lutz Swantje Held Burkhard Deuß Tobias Göser Dirk Waldschmidt Christiane Bruns Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
description	Abstract Background According to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available. Methods In this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas. The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma. In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection. Discussion This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer. Trial registration numbers EudraCT 2019–002734-37 ; NCT04617457 .
format	article
author	Florian Gebauer Alexander Ioannis Damanakis Felix Popp Alexander Quaas Fabian Kütting Katrin Lutz Swantje Held Burkhard Deuß Tobias Göser Dirk Waldschmidt Christiane Bruns
author_facet	Florian Gebauer Alexander Ioannis Damanakis Felix Popp Alexander Quaas Fabian Kütting Katrin Lutz Swantje Held Burkhard Deuß Tobias Göser Dirk Waldschmidt Christiane Bruns
author_sort	Florian Gebauer
title	Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
title_short	Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
title_full	Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
title_fullStr	Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
title_full_unstemmed	Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)
title_sort	study protocol of an open-label, single arm phase ii trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with oxaliplatin and 5-fluorouracil/folinic acid followed by curative surgical resection in patients with hepatic oligometastatic adenocarcinoma of the pancreas (holipanc)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/616c088826884c7d99c7984e35c6d4f5
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