Spots Global Cancer Trial Database for Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma
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Trial Identification
Brief Title: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma
Official Title: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I)
Study ID: NCT04402073
Conditions
Study Description
Brief Summary: Medulloblastoma is a rare brain malignancy, mainly affecting children. Treatment of this rapidly growing tumor begins with maximal surgical removal plus radiation and chemotherapy. Treatment toxicity is high. Post-pubertal and pediatric medulloblastomas are biologically and prognostically different, which mandates age-adapted treatment strategies. Patients after puberty bear an intermediate to high prognostic risk. This means that a large number of these patients, are faced with death and/or disability (mainly neurocognitive). Therefore, the scientific and medical need is high. One of the genetic subgroups of medulloblastoma, the SHH-subgroup (Sonic HedgeHog- subgroup), is highly overrepresented in medulloblastoma patients after puberty. This subgroup can be treated with a targeted therapy. The investigators will therefore randomize patients and treat SHH-subgroup patients with sonidegib and a reduction of radiotherapy dose in the experimental arm of the trial. The hypothesis that this personalized risk-adapted therapy will improve outcomes in view of increased efficacy and decreased toxicity.
Detailed Description:
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Adelaide Hospital, Adelaide, , Australia
Princess Alexandra Hospital - University Of Queensland, Brisbane, , Australia
Austin Health - Austin hospital, Melbourne, , Australia
Peter Maccallum Cancer Institute, Melbourne, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
John Hunter Children's Hospital, New Lambton Heights, , Australia
Prince Of Wales Hospital, Sydney, , Australia
Royal North Shore Hospital, Sydney, , Australia
Sydney Children's Hospital, Sydney, , Australia
Westmead Hospital - Crown Princess Mary Cancer Center, Westmead, , Australia
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik, Innsbruck, , Austria
AKH unikliniken, Wien, , Austria
CHRU de Lille, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital de La Timone (APHM), Marseille, , France
CHU de Nice - Hopital Pasteur, Nice, , France
Hopital la Pitie-Salpetriere, Paris, , France
Institut de Cancerologie de l'Ouest (ICO) - Saint Herblain, Saint-Herblain, , France
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole, Toulouse, , France
Knappschaft Krankenhaus Langendreer, Bochum, , Germany
Universitaetsklinikum Bonn, Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
HELIOS Kliniken - HELIOS Klinikum Erfurt GmbH, Erfurt, , Germany
Universitaetsklinikum - Essen, Essen, , Germany
University Frankfurt - Goethe Univ. - University Hospital Frankfurt -Senckenberg Institute of Neurooncology, Frankfurt, , Germany
Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie, Freiburg, , Germany
Universitaetsmedizin Goettingen - Georg-August Universitaet, Goettigen, , Germany
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center, Hamburg, , Germany
Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital, Heidelberg, , Germany
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie, Leipzig, , Germany
Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz, , Germany
UniversitaetsMedizin Mannheim, Mannheim, , Germany
Klinikum Rechts der isar Der Technische Universitaet Muenchen, Munich, , Germany
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern, Munich, , Germany
Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg, Regensburg, , Germany
Universitaetsklinikum Tuebingen- Crona Kliniken, Tuebingen, , Germany
AUSL Bologna - Ospedale Bellaria, Bologna, , Italy
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi, Florence, , Italy
IRCCS - Istituto Neurologico Carlo Besta, Milano, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, , Italy
ULSS2 - Marca Trevigniana, Treviso, , Italy
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, , Switzerland
University Hospital zurich, Zürich, , Switzerland
Contact Details
Name: Peter Hau
Affiliation: EORTC study coordinator
Role: PRINCIPAL_INVESTIGATOR
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