EORTC-2227-BTG

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Lomustine with and without reirradiation for first progression of glioblastoma: a randomized phase III study

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 15-Mar-2024
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	All Groups: 490
Treatment	Radiotherapy, Drug Lomustine
Study Staff	Matthias Preusser (Study Coordinator) , Universitaetsklinikum Wien - AKH unikliniken, Vienna Christian Alfano (Project Manager) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Jozefien Debruyne (Junior PVM) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Lucia Gonzalez (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels Tomas Kazda (Y-ECI Coordinator) , Masaryk Memorial Cancer Institute, Brno Stephane Lejeune (International Affairs and Policies Manager) , EORTC Headquarters, Brussels Abigirl Machingura (QoL Specialist) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Anja Mestnik (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Giuseppe Minniti (Study Co-Coordinator) , Azienda ospedaliero Univ Policlinico Umberto I, Roma Ana Oliveira (Data Manager) , EORTC Headquarters, Brussels Caroline Quoilin (Medical representative) , EORTC Headquarters, Brussels Maira Seini (Senior Regulatory Affairs Manager) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels Lotte van der Weijst (QoL Specialist) , EORTC Headquarters, Brussels
Type of cancer	Brain
Participating groups	EORTC Brain Tumor Group
Recruiting centers	A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria) Erasmus MC (Rotterdam, Netherlands) Kepler University Hospital - Neuromed campus (Linz, Austria) Masaryk Memorial Cancer Institute (Brno, Czech Republic) Medisch Spectrum Twente (Enschede, Netherlands) Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany) Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany) Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria)
Centers to be activated	APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy) Azienda ospedaliero Univ Policlinico Umberto I (Roma, Italy) CHRU de Lille (LILLE CEDEX, France) CHU Amiens Picardie - Site Sud (Amiens, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) CHU de Nice - Hopital Pasteur (NICE, France) CLCC - Jean Perrin (CLERMONT FERRAND , France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Hospital Universitario 12 De Octubre (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS--Ospedale Bellaria-Bologna (Bologna, Italy) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Leiden University Medical Centre (Leiden, Netherlands) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark) St. Olavs Hospital, Trondheim University Hospital (Trondheim, Norway) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany) Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland) Universitaetsklinikum Erlangen-Schwabachanlage (Erlangen, Germany) Universitaetsklinikum Koeln (Koeln, Germany) Universitaetsklinikum Regensburg (Regensburg, Germany) Universitaetsspital Basel (Basel, Switzerland)
Protocol summary	http://clinicaltrials.gov/study/NCT05904119
NCT number	NCT05904119
Financial Support	Brain Tumor Group Horizon