EORTC-1634-BTG

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Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly-Diagnosed Medulloblastoma (PersoMed-I)

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 11-Nov-2022
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 205 - All Groups: 205
Treatment	Drug Cisplatin, Vincristine, Lomustine, Sonidegib
Study Staff	Peter Hau (Study Coordinator) , Universitaetsklinikum Regensburg, Regensburg Najlaa Alyamani (Clinical Research Physician) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Fabio Borges (Project Manager) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Hazal Erkol (Data Manager) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Sarah Kelly (QART Manager) , EORTC Headquarters, Brussels Sylvie Ledroit (Clinical Operations Assistant) , EORTC Headquarters, Brussels Jeremy Leys (Clinical Operations Manager) , EORTC Headquarters, Brussels Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Caroline Quoilin (Clinical Scientist) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels
Type of cancer	Brain
Participating groups	EORTC Brain Tumor Group Cooperative Trials Group for Neuro-Oncology Neuroonkologische Arbeitsgemeinschaft
Recruiting centers	Austin Health - Austin hospital (Heidelberg VIC, Australia) CHU de Nice - Hopital Pasteur (NICE, France) Centre Leon Berard (Lyon, France) Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Erasmus MC (Rotterdam, Netherlands) HELIOS Klinikum Erfurt GmbH (Erfurt, Germany) HELIOS Klinikum Erfurt GmbH (Erfurt, Germany) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France) Hospital Clinic de Barcelona (Barcelona, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) Peter Maccallum Cancer Institute (Melbourne, Australia) Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) Royal Adelaide Hospital (Adelaide, Australia) Royal North Shore Hospital (St Leonards, Australia) Staedtisches Klinikum Muenchen - Klinikum Schwabing (Muenchen, Germany) Sydney Children's Hospital (Randwick, Australia) Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany) UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) UniversitaetsMedizin Mannheim (Mannheim, Germany) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Bonn (Bonn, Germany) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie (Freiburg, Germany) Universitaetsklinikum Freiburg - Zentrum fuer Kinder u Jugend med. (Freiburg, Germany) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany) Universitaetsklinikum Regensburg (Regensburg, Germany) Universitaetsklinikum Regensburg (Regensburg, Germany) Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany) Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany) Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany) University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany)
Centers to be activated	A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) AUSL Bologna - Ospedale Bellaria (Bologna, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy) CHRU de Lille (LILLE CEDEX, France) CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) John Hunter Children’s Hospital (Newcastle, Australia) Odense University Hospital (Odense C, Denmark) Prince Of Wales Hospital (Randwick - Sydney, Australia) Sir Charles Gairdner Hospital (Nedlands, Australia) ULSS2 - Marca Trevigniana (Treviso, Italy) ULSS2 - Marca Trevigniana (Treviso, Italy) Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland) Universitaetsklinikum- Heidelberg HOPP Kindertumorzentrum (Heidelberg, Germany) University Medical Center Groningen (Groningen, Netherlands) Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia)
Protocol summary	http://clinicaltrials.gov/study/NCT04402073
NCT number	NCT04402073
EudraCT	2020-003063-26
Financial Support	Gateway for Cancer Research LeonBerard PHRC-K Drug Only Sun Pharma