Study
EORTC-1634-BTG
Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly-Diagnosed Medulloblastoma (PersoMed-I)
Trial Status
Recruiting
Dates
Date of activation: 11-Nov-2022
Data management at EORTC
Yes
Design
Phase 2
Randomized open label
Randomized open label
Targeted Sample size
EORTC Groups: 205 - All Groups: 205
Treatment
Drug
Cisplatin, Vincristine, Lomustine, Sonidegib
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
- 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, Clinical Research Physician), EORTC Headquarters, Brussels
- Luiza Souza (QART Manager), EORTC Headquarters, Brussels
- Maarten Spruyt (Data Manager), EORTC Headquarters, Brussels
- Laurien Vancleef (Clinical Operations 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)
- Hopital de La Timone (APHM) (MARSEILLE, 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)
- 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 Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
- Universitaetsklinikum Regensburg (Regensburg, 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)
- 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)
- 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)
- 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
NCT number
NCT04402073