Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial

Abstract Background Cytotoxic chemotherapy combinations and targeted agents represent established treatment concepts in advanced pancreatic neuroendocrine tumors (PNETs). However, response rates, side effects and outcome data strongly vary among these therapeutic approaches. Head-to-head comparisons...

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Autores principales:	Sebastian Krug, Thomas Kegel, Thomas M. Gress, Anja Rinke, Leonidas Apostolidis, Henning Jann, Alexander König, Dieter Hörsch, Jörg Schrader, Thomas J. Ettrich, Michael Richter, Jörg Steighardt, Patrick Michl
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	PanNET PNET Chemotherapy Ramucirumab DTIC Neuroendocrine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/19ea4eac44d448f1a68eca27024409f7
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spelling	oai:doaj.org-article:19ea4eac44d448f1a68eca27024409f72021-11-14T12:30:45ZRamucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial10.1186/s12885-021-08900-71471-2407https://doaj.org/article/19ea4eac44d448f1a68eca27024409f72021-11-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08900-7https://doaj.org/toc/1471-2407Abstract Background Cytotoxic chemotherapy combinations and targeted agents represent established treatment concepts in advanced pancreatic neuroendocrine tumors (PNETs). However, response rates, side effects and outcome data strongly vary among these therapeutic approaches. Head-to-head comparisons between chemo- and molecular therapies are missing and secondary resistances frequently occur. The RamuNET trial aims to identify the effectiveness of dual treatment with DTIC and ramucirumab in progressive advanced PNET patients. Methods The RamuNET study is an investigator-initiated multicenter prospective single-arm trial to evaluate the efficacy of ramucirumab in combination with dacarbazine (DTIC) over a period of at least 6 months. Patients with progressive well-differentiated and metastatic pancreatic neuroendocrine tumors are eligible. The study aims to include 45 patients over a period of 24 months with a minimum follow-up of 24 months. The primary endpoint is disease control after 6 months. Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity. Based on the hypothesis that 80% of the patients can achieve a disease control after 6 months, the sample size calculation follows an exact binomial single-stage design. H0: p < =p0 = 60% versus H1: p > =p1 = 80%, alpha = 0.05, beta = 0.1. Discussion This study investigates a new therapeutic approach using the combination of cytotoxic and targeted antiangiogenic therapy in advanced PNET. If positive, this trial will be the basis for a randomized two-arm study to investigate the combination of ramucirumab and DTIC against other established therapies in PNET. Trial registration EudraCT: 2017–001207-68 . Date of registration: 2018.01.03.Sebastian KrugThomas KegelThomas M. GressAnja RinkeLeonidas ApostolidisHenning JannAlexander KönigDieter HörschJörg SchraderThomas J. EttrichMichael RichterJörg SteighardtPatrick MichlBMCarticlePanNETPNETChemotherapyRamucirumabDTICNeuroendocrineNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	PanNET PNET Chemotherapy Ramucirumab DTIC Neuroendocrine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	PanNET PNET Chemotherapy Ramucirumab DTIC Neuroendocrine Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Sebastian Krug Thomas Kegel Thomas M. Gress Anja Rinke Leonidas Apostolidis Henning Jann Alexander König Dieter Hörsch Jörg Schrader Thomas J. Ettrich Michael Richter Jörg Steighardt Patrick Michl Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
description	Abstract Background Cytotoxic chemotherapy combinations and targeted agents represent established treatment concepts in advanced pancreatic neuroendocrine tumors (PNETs). However, response rates, side effects and outcome data strongly vary among these therapeutic approaches. Head-to-head comparisons between chemo- and molecular therapies are missing and secondary resistances frequently occur. The RamuNET trial aims to identify the effectiveness of dual treatment with DTIC and ramucirumab in progressive advanced PNET patients. Methods The RamuNET study is an investigator-initiated multicenter prospective single-arm trial to evaluate the efficacy of ramucirumab in combination with dacarbazine (DTIC) over a period of at least 6 months. Patients with progressive well-differentiated and metastatic pancreatic neuroendocrine tumors are eligible. The study aims to include 45 patients over a period of 24 months with a minimum follow-up of 24 months. The primary endpoint is disease control after 6 months. Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity. Based on the hypothesis that 80% of the patients can achieve a disease control after 6 months, the sample size calculation follows an exact binomial single-stage design. H0: p < =p0 = 60% versus H1: p > =p1 = 80%, alpha = 0.05, beta = 0.1. Discussion This study investigates a new therapeutic approach using the combination of cytotoxic and targeted antiangiogenic therapy in advanced PNET. If positive, this trial will be the basis for a randomized two-arm study to investigate the combination of ramucirumab and DTIC against other established therapies in PNET. Trial registration EudraCT: 2017–001207-68 . Date of registration: 2018.01.03.
format	article
author	Sebastian Krug Thomas Kegel Thomas M. Gress Anja Rinke Leonidas Apostolidis Henning Jann Alexander König Dieter Hörsch Jörg Schrader Thomas J. Ettrich Michael Richter Jörg Steighardt Patrick Michl
author_facet	Sebastian Krug Thomas Kegel Thomas M. Gress Anja Rinke Leonidas Apostolidis Henning Jann Alexander König Dieter Hörsch Jörg Schrader Thomas J. Ettrich Michael Richter Jörg Steighardt Patrick Michl
author_sort	Sebastian Krug
title	Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
title_short	Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
title_full	Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
title_fullStr	Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
title_full_unstemmed	Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial
title_sort	ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (ramunet): study protocol for a multicenter single-arm trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/19ea4eac44d448f1a68eca27024409f7
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Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial

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