Study

EORTC-1634-BTG

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

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 11-Nov-2022
Date Step1 close: 20-Mar-2024

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
  • Tina Verschuere (Project Manager), EORTC Headquarters, Brussels
  • Jose Silva (Clinical Research Physician), EORTC Headquarters, Brussels
  • Caroline Quoilin (Clinical Scientist), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Thierry Gorlia (Statistician), EORTC Headquarters, Brussels
  • Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
  • Jerome Rapion (Statistical Analyst), EORTC Headquarters, Brussels
  • Cedric Mallien (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Benedicte Demeulder (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Antimo Razzino (Data Manager), EORTC Headquarters, Brussels
  • Maarten Spruyt (Data Manager), EORTC Headquarters, Brussels
  • Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Lore Hermans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
  • Hafida Lmalem (Imaging Officer), EORTC Headquarters, Brussels
  • Enrico Clementel (QART Manager), EORTC Headquarters, Brussels
  • Coreen Corning (QART Manager), EORTC Headquarters, Brussels
  • Sarah Kelly (QART Manager), EORTC Headquarters, Brussels
  • Luiza Souza (QART 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, 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)
  • Medical University of Vienna, University Hospital AKH Vienna (Vienna, Austria)
  • 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)
  • 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)

Protocol summary

http://clinicaltrials.gov/study/NCT04402073

NCT number

NCT04402073

EudraCT

2020-003063-26