Last updated on February 2018

Efficacy and Safety of Everolimus and (STZ-5FU) Given One Upfront the Other Upon Progression in Advanced pNET


Brief description of study

The purpose of this study is to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.

Detailed Study Description

STZ based chemotherapy, STZ-5FU, is the actual standard of care for advanced pancreatic Neuroendocrine tumours (pNETS) in the European Union. Everolimus has been recently approved for its use in advanced pNETs by the Food and Drug Administration (FDA) and in Europe by the European Medical Agency (EMA).

A randomized study is needed to have a clear knowledge about the best sequence for its administration; this is, before or after palliative chemotherapy.

There may or may not be any benefits from giving first each other treatment of the study. The information obtained from this study will help the physician improve the treatment and management of patients with advanced pNET.

Clinical Study Identifier: NCT02246127

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Morten Ladekarl

Aarhus Aarhus University Hospital NET Centre (AUH-NET)
Aarhus, Denmark
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Ulrich Peter Knigge

Rigshospitalet NET CoE, University of Copenhagen
Copenhagen, Denmark
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Derk Jan de groot

UMCG / University of Groningen
Groningen, Denmark
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Judith de Vos-Geelen

Maastricht UMC
Maastricht, Denmark
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Lene Vestermark

Odense University Hospital
Odense, Denmark
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Jean-Philippe Metges

Brest Hopital Augustin Morvan, Institut de Cancero-Hemato
Brest, France
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Philippe Ruszniewski

Clichy Neuroendocrine Tumor (NET) Center Hopital Beaujon
Clichy, France
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Eric Baudin

Institut Gustave-Roussy
Villejuif, France
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Bernard Goichot

H pitaux Universitaires de Strasbourg H pital de Hautepierre
Strasbourg, France
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Francois-Xavier Caroli-Bosc

UTTIOM Unit Transversale de Th rapeutiques Innovantes en Oncologie M dicale CHU Angers
Anger, France
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Denis Smith

University Hospital of Bordeaux H pital Saint-Andr
Bordeaux, France
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Thomas Walter

H pital Edouard Herriot
Lyon, France
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Jean-Francois Seitz

H pital La Timone
Marseille, France
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Dieter Hörsch

Bad Berka ChA Klinik f r Innere Medizin
Bad Berka, Germany
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Frank Ulrich Pape

Berlin Charit Universit tsmedizin
Berlin, Germany
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Sebastian Krug

UKM Facharzt f r Innere Medizin Gastroenterologie, Onkologische Gastroenterologie (DGVS)
Halle, Germany
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Joerg Schrader

Medizinische Klinik und Poliklinik , Universit tsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Peter Malfertheiner

Magdeburg Universit tsklinikum Magdeburg A. . R
Magdeburg, Germany
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Mathias Weber

Mainz Universit tsmedizin
Mainz, Germany
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Anja Rinke

Marburg Universit tsklinikum Giessen und Marburg GmbH
Marburg, Germany
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Carlo Carnaghi

Istituto Europeo di Oncologia- IRCCS
Milano, Italy
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Salvatore Tafuto

Istituto Nazionale Tumori (Fondazione G Pascale)
Napoli, Italy
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Heinz-Josef Klümpen

Amsterdam Academic Medical Center
Amsterdam, Netherlands
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Paula Jimenez Fonseca

Hospital Central de Asturias
Oviedo, Spain
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Jose Luis Manzano

Hospital Universitario Germans Trias i Pujol
Badalona, Spain
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Alexander Teule

Instituto Catal n de Oncolog a de Hospitalet
L'Hospitalet de Llobregat, Spain
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Marta Martin

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
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Jaume Capdevila

Hospital Universitario Vall d'Hebron
Barcelona, Spain
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Rocío García-Carbonero

Hospital Universitario 12 de Octubre
Madrid, Spain
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Marta Benavent

Hospital Universitario Virgen del Roc o
Sevilla, Spain
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Barbro Eriksson

University Hospital
Uppsala, Sweden
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Nicholas Simon Reed

West of Scotland Cancer Centre Gartnavel General Hospital
Beatson, United Kingdom
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Birgit Cremer

K ln Universit tsklinikum K ln (A R)
Köln, Germany
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Christoph Josef Auernhammer

Interdisciplinary Center of Neuroendocrine Tumors of the GastroEnteroPancreatic System (GEPNET-KUM) at the University of Munich
München, Germany
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Alexander von Werder

Medizin II am Klinik und Poliklinik rechts der Isar
München, Germany
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Maria Isabel Sevilla

HCU Virgen de la Victoria
Málaga, Spain
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