Clinical Trial Details

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
Jessica Berger (Clinical Research Associate/Monitor) , 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
Jeremy Leys (Clinical Operations Manager) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Caroline Quoilin (Clinical Scientist) , EORTC Headquarters, Brussels
Jose Silva (Medical representative) , EORTC Headquarters, Brussels
Jose Silva (Clinical Research Physician) , EORTC Headquarters, Brussels
Luiza Souza (QART Manager) , EORTC Headquarters, Brussels
Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
Cooperative Trials Group for Neuro-Oncology
Neuroonkologische Arbeitsgemeinschaft
Recruiting centers A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria)
Austin Health - Austin hospital (Heidelberg VIC, Australia)
CHU de Nice - Hopital Pasteur (NICE, France)
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, 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)
Prince Of Wales Hospital (Randwick - Sydney, 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)
Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia)
Centers to be activated 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)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Gustave Roussy (VILLEJUIF CEDEX, France)
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)
Sir Charles Gairdner Hospital (Nedlands, Australia)
ULSS2 - Marca Trevigniana (Treviso, Italy)
ULSS2 - Marca Trevigniana (Treviso, Italy)
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)
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