Clinical trial • Phase III • Oncology

TEMOZOLOMIDE for Medulloblastoma | High-risk medulloblastoma

Phase III trial of TEMOZOLOMIDE for Medulloblastoma | High-risk medulloblastoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Medulloblastoma | High-risk medulloblastoma
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
09-10-2024
First CTIS Authorization Date
06-11-2024

Trial design

Randomised, arm a: conventional (once a day) radiotherapy (standard therapy); arm b: hyperfractionated-accelerated radiotherapy (hart). high-dose therapy (hdt) with thiotepa followed by conventional radiotherapy is included as an alternative treatment strategy. there are two different maintenance chemotherapy strategies to be compared (maintenance regimens not detailed in part i data).-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Arm A: conventional (once a day) radiotherapy (standard therapy); Arm B: hyperfractionated-accelerated radiotherapy (HART). High-dose therapy (HDT) with thiotepa followed by conventional radiotherapy is included as an alternative treatment strategy. There are two different maintenance chemotherapy strategies to be compared (maintenance regimens not detailed in Part I data).
Target Sample Size
443

Eligibility

Recruits 443 paediatric patients.

Pregnancy Exclusion
Females who are pregnant or breastfeeding
Vulnerable Population
Includes children, adolescents and young adults (age at diagnosis ≥3 years, population includes minors). Written informed consent from the patient and/or parent/legal guardian is required. Age-specific information sheets and consent/assent forms are provided (documents for under 12, 12-14, 15-17, 18+ and parent/guardian versions) in multiple languages for participating countries.

Inclusion criteria

  • {"criterion_text":"- Histologically proven (centrally reviewed) high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with SHH or non-SHH/non-WNT (Groups 3 and 4) medulloblastoma, with at least one of the following high risk features: Metastatic disease- Chang Stage M1, M2 and M3, Large cell/anaplastic MB (as defined by WHO criteria 2016 [1]), Patients with MYC or MYCN amplified tumours (unless MYCN amplified non-WNT/non-SHH Group 4 without any other high risk factors), Patients with somatic SHH-TP53 mutant tumours, Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and other biological risk factors (as above)\n- Documented negative pregnancy test for female patients of childbearing potential\n- Patient agrees to use effective contraception whilst on treatment (patients of childbearing potential)\n- Written informed consent from the patient and/or parent/legal guardian\n- For Randomisation 2 ONLY: Patient entered into the SIOP-HRMB trial at diagnosis\n- For Randomisation 2 ONLY: Patient treated with: Either Arm A (conventional radiotherapy) or Arm B (HART)\n- Age at diagnosis ≥3 years. The date of diagnosis is the date on which initial surgery is undertaken\n- Submission of biological material, including fresh frozen tumour samples and blood, in accordance with national and international schemes for molecular genetic assessment of biological markers, and for associated biological studies.\n- No prior treatment for medulloblastoma, other than surgery, with the exception of one cycle of induction chemotherapy with carboplatin and etoposide may be given prior to trial entry and randomisation where there is clinical urgency to start treatment\n- Adequate hepatic function defined as: Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert’s syndrome OR ALT or AST < 2.5 X ULN for age\n- Adequate renal function defined as creatinine < 1.5 x ULN\n- Adequate haematological function defined as neutrophils ≥1 x 109/L; platelets ≥ 100 x 109/L, prior to induction chemotherapy\n- No significant hearing deficit in at least one ear (significant hearing deficit defined as Chang grade 3 or above)\n- Medically fit to receive treatment"}

Exclusion criteria

  • {"criterion_text":"- Patients with proven or with high likelihood of germline TP53, APC, PTCH1, SUFU, PALB2, BRCA2 gene alteration or any other DNA repair defect.\n- Females who are pregnant or breastfeeding\n- Patients who cannot be regularly followed up due to psychological, social, family, geographical or other issues\n- Patients for whom non-compliance with treatment, management guidelines or monitoring is expected\n- Non-WNT/non-SHH Group 4 patients with MYCN amplification and no other high-risk factor\n- Patients with CTNNB1 mutation positive WNT medulloblastoma irrespective of other risk factors\n- Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and no other biological risk factors\n- Chang Stage M4 disease\n- Brainstem or embryonal tumours in other sites\n- Patients previously treated for a brain tumour or any type of malignant disease\n- Medical contraindication to radiotherapy or chemotherapy\n- Known hypersensitivity to any of the treatments or excipients"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-free survival","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
443
Recruitment Window Months
87
Consent Approach
Written informed consent from the patient and/or parent/legal guardian is required. Age-specific consent and information materials provided (under 12, 12-14, 15-17, 18+ and parent/guardian forms). Multiple language versions provided across participating countries (examples: English, German, French, Dutch, Czech, Danish, Finnish, Swedish, Norwegian).

Geography

Total Number Of Sites
88
Total Number Of Participants
407

Austria

Latest Decision Or Authorization Date
15-12-2024
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
Medical University Of Graz
Department Name
Univ.-Klinik für Kinder- und Jugendheilkunde
Contact Person Name
Thomas Perwein
Contact Person Email
thomas.perwein@medunigraz.at
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Andreas Peyrl
Contact Person Email
andreas.peyrl@meduniwien.ac.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department für Kinder- und Jugendheilkunde
Contact Person Name
Roman Crazzolara
Contact Person Email
Roman.Crazzolara@i-med.ac.at
Site Name
St. Anna Kinderspital GmbH
Department Name
St. Anna Kinderspital
Contact Person Name
Herbert Pichler
Contact Person Email
Herbert.pichler@stanna.at

Belgium

Latest Decision Or Authorization Date
07-11-2024
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Pédiatrie hémato-oncologie
Contact Person Name
Laurence Dedeken
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Hémato - oncologie pédiatrique
Contact Person Name
Caroline Piette
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hématologie et oncologie pédiatrique
Contact Person Name
An Van Damme
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatrische hemato-oncologie
Contact Person Name
Leen Willems
Contact Person Email
leen.willems@uzgent.be
Site Name
CHC MontLegia
Department Name
Hémato - oncologie pédiatrique
Contact Person Name
Christophe Chantrain
Contact Person Email
christophe.chantrain@chc.be
Site Name
UZ Leuven
Department Name
Kinderhemato-oncologie
Contact Person Name
Sandra Jacobs
Contact Person Email
sandra2.jacobs@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Kinderhemato-oncologie
Contact Person Name
Joris Verlooy
Contact Person Email
joris.verlooy@uza.be

Czechia

Latest Decision Or Authorization Date
08-11-2024
Number Of Sites
2
Number Of Participants
24

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Klinika dětské hematologie a onkologie
Contact Person Name
Zdeněk Pavelka
Contact Person Email
Pavelka.Zdenek@fnbrno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika dětské onkologie
Contact Person Name
Michal Zápotocký
Contact Person Email
Michal.zapotocky@fnmotol.cz

Denmark

Latest Decision Or Authorization Date
11-11-2024
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Rigshospitalet
Department Name
Department of paediatric and adolescent medicine
Contact Person Name
Astrid Sehested
Site Name
Aarhus Universitetshospital
Department Name
Department of paediatric and adolescent medicine
Contact Person Name
Torben Mikkelsen
Contact Person Email
torbmikk@rm.dk
Site Name
Odense University Hospital
Department Name
Hans Christian Andersen Children's Hospital
Contact Person Name
Michael Callesen
Contact Person Email
michael.callesen@rsyd.dk

Finland

Latest Decision Or Authorization Date
12-11-2024
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
HUS-Yhtymae
Department Name
HUS, Lasten ja nuorten sairaudet, lasten veri- ja syöpätaudit ja kantasolusiirrot
Contact Person Name
Virve Pentikäinen
Contact Person Email
virve.pentikainen@hus.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Turun yliopistollinen sairaala, Lasten veri- ja syöpätaudit
Contact Person Name
Laura Korhonen
Contact Person Email
laura.korhonen@varha.fi
Site Name
Pirkanmaan hyvinvointialue
Department Name
Tampereen yliopistollinen sairaala, Lasten veri- ja syöpätautien yksikkö
Contact Person Name
Kristiina Nordfors
Contact Person Email
kristiina.nordfors@pirha.fi
Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Oulun yliopistollinen sairaala, Lasten ja nuorten tulosalue
Contact Person Name
Anne Hekkala
Contact Person Email
anne.hekkala@pohde.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Kuopion yliopistollinen sairaala, Lasten veri- ja syöpätautien osasto
Contact Person Name
Jouni Pesola

Germany

Latest Decision Or Authorization Date
08-11-2024
Number Of Sites
42
Number Of Participants
147

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Kinder- und Jugendmedizin
Contact Person Name
Lisa Nonnenmacher
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Kinderonkologie Station A5
Contact Person Name
Meinolf Siepermann
Contact Person Email
siepermannm@kliniken-koeln.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Kinder- und Jugendmedizin
Contact Person Name
Patrick Hundsdörfer
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Kinderheilkunde III
Contact Person Name
Kristian Pajtler
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Päd. Hämatologie, Onkologie und Stammzelltransplantation
Contact Person Name
Marcus Jakob
Contact Person Email
Marcus.Jakob@ukr.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Thorsten Langer
Contact Person Email
thorsten.langer@uksh.de
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Kinderonkologie/ Hämatologie
Contact Person Name
Aram Prokop
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Christian Kratz
Contact Person Email
kratz.christian@mh-hannover.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Kinder-und Jugendmedizin
Contact Person Name
Ralf Knöfler
Contact Person Email
ralf.knoefler@ukdd.de
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
päd. Onkologie
Contact Person Name
Georg Schwabe
Contact Person Email
g.schwabe@ctk.de
Site Name
Sana Kliniken Duisburg GmbH
Department Name
Kinderklinik
Contact Person Name
Tanja Höll
Contact Person Email
tanja.hoell@sana.de
Site Name
Johannes Wesling Klinikum Minden
Department Name
Eltern-Kind-Zentrum (ELKI)
Contact Person Name
Bernhard Erdlenbruch
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Christine Mauz-Körholz
Site Name
Universitaet Leipzig
Department Name
Abteilung für Päd. Hämatologie, Onkologie und Hämostaseologie
Contact Person Name
Lars Fischer
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin
Contact Person Name
Caspar Kühnöl
Contact Person Email
caspar.kuehnoel@uk-halle.de
Site Name
University Hospital Cologne AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Thorsten Simon
Contact Person Email
thorsten.simon@uk-koeln.de
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Onkologie und Hämatologie
Contact Person Name
Alfred Leipold
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Päd. Onkologie und Hämatologie
Contact Person Name
Paul-Gerhardt Schlegel
Contact Person Email
schlegel_p@ukw.de
Site Name
HELIOS Klinikum Krefeld GmbH
Department Name
Hämatologie und Onkologie
Contact Person Name
Thomas Imschweiler
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Kinderheilkunde III
Contact Person Name
Gudrun Fleischhack
Contact Person Email
Gudrun.Fleischhack@uk-essen.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Zentrum für Kinder-, Jugend- und Frauenmedizin
Contact Person Name
Claudia Blattmann
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Abteilung für Hämatologie/Onkologie
Contact Person Name
Christian Braun
Contact Person Email
Ch.braun@med.uni-muenchen.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Päd. Onkologie und Hämatologie
Contact Person Name
Stefanie Huber
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abt. I, Allgemeinpädiatrie, Hämatologie/Onkologie
Contact Person Name
Martin Ebinger
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Martin Chada
Contact Person Email
martin.chada@uk-erlangen.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Antje Redlich
Contact Person Email
antje.redlich@med.ovgu.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Martina Rodehüser
Contact Person Email
martina.rodehuser@gnh.net
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Johanna Scheer-Preiss
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Eltern-Kind-Zentrum Prof. Hess Kinderonkologie
Contact Person Name
Arnulf Pekrun
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel site)
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Simon Vieth
Contact Person Email
simon.vieth@uksh.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Stefan Rutkowski
Contact Person Email
s.rutkowski@uke.de
Site Name
Goethe University Frankfurt
Department Name
Zentrum für Kinder- und Jugendmedizin
Contact Person Name
Anke Barnbrock
Contact Person Email
anke.barnbrock@ukffm.de
Site Name
Gemeinschaftskrankenhaus Herdecke gGmbH
Department Name
Kinder- und Jugendmedizin
Contact Person Name
Alfred Längler
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Kinderonkologisches Zentrum
Contact Person Name
Jörg Faber
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Päd. Onkologie und Hämatologie
Contact Person Name
Arne Simon
Contact Person Email
arne.simon@uks.de
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Axel Sauerbrey

Italy

Latest Decision Or Authorization Date
19-11-2024
Number Of Sites
12
Number Of Participants
100

Sites

Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOS (Simple Departmental Operational Unit) at the Department of Hemato-Oncology
Contact Person Name
Claudia Milanaccio
Contact Person Email
claudiamilanaccio@gaslini.org
Site Name
ARNAS G. Brotzu
Department Name
Pediatric Oncohematology
Contact Person Name
Rosamaria Mura
Contact Person Email
rosamaria.mura@aob.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O.C. (Complex operating unit) of Pediatric Hemato-Oncology and Bone Marrow Transplant
Contact Person Name
Milena La spina
Contact Person Email
mlaspina@unict.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. (Complex Operating Unit) Pediatric Oncohematology
Contact Person Name
Elisabetta Viscardi
Contact Person Email
elisabetta.viscardi@unipd.it
Site Name
Azienda Ospedaliera Santobono Pausilipon
Department Name
Department of oncohematology
Contact Person Name
Lucia Quaglietta
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. (Complex structure) Pediatric Oncohematology and Transplant Center
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it
Site Name
University Hospital Consorziale Policlinico (Bari)
Department Name
Hospital Pediatrics with oncohematological address
Contact Person Name
Nicola Santoro
Contact Person Email
nico.santoro1956@libero.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
U.O.C. (Complex operating unit) Pediatric Oncohematology and Transplant Center
Contact Person Name
Simone Cesaro
Contact Person Email
simonce.cesaro@aovr.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
Pediatric Oncohematology
Contact Person Name
Paola Coccia
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Department of Oncology-Pediatric Hematology and Transfusion Medicine
Contact Person Name
Angela Mastronuzzi
Contact Person Email
angela.mastronuzzi@opbg.net
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
S.S.D. (Simple departmental structure) of pediatric oncohematology
Contact Person Name
Fraia Melchionda
Contact Person Email
fraia.melchionda@aosp.bo.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Maternal and child Department - Pediatric clinic
Contact Person Name
Chiara Pilotto

Sweden

Latest Decision Or Authorization Date
07-11-2024
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Queen Silvia Children's Hospital
Department Name
Queen Silvia Children`s Hospital
Contact Person Name
Magnus Sabel
Contact Person Email
magnus.sabel@vregion.se
Site Name
Uppsala University Hospital
Department Name
Pediatric hematology and oncology
Contact Person Name
Geraldine Giraud
Contact Person Email
geraldine.giraud@akademiska.se
Site Name
Skåne University Hospital
Department Name
Children´s Cancer Center
Contact Person Name
Helena Mörse
Contact Person Email
helena.morse@skane.se
Site Name
University Hospital (Linköping)
Department Name
Crown Princess Victoria Children´s Hospital
Contact Person Name
Per Nyman
Site Name
Norrlands Universitetssjukhus
Department Name
Department of Pediatric Oncology and Hematology, Children and Youth Center
Contact Person Name
Magnus Borssén
Contact Person Email
magnus.borssen@vasterbotten.se
Site Name
Astrid Lindgren Children´s Hospital, Karolinska University Hospital
Department Name
Astrid Lindgrens Childrens Hospital
Contact Person Name
Kleopatra Georgantzi

Netherlands

Latest Decision Or Authorization Date
06-11-2024
Number Of Sites
2
Number Of Participants
29

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Radiation Oncology
Contact Person Name
John Maduro
Contact Person Email
j.h.maduro@umcg.nl
Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Neuro-oncology
Contact Person Name
Sabine Plasschaert

Norway

Latest Decision Or Authorization Date
12-11-2024
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Oslo University Hospital HF
Department Name
Pediatric hematology and oncology
Contact Person Name
Einar Stensvold
Contact Person Email
einar.stensvold@ous-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Pediatric hematology and oncology
Contact Person Name
Magnus Hjort
Contact Person Email
Magnus.aasved.hjort@stolav.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Pediatric hematology and oncology
Contact Person Name
Ole Mikael Wormdal
Contact Person Email
ole.mikal.wormdal@unn.no
Site Name
Haukeland Universitetssykehus
Department Name
Pediatric hematology and oncology
Contact Person Name
Ingrid Torsvik

Sponsor

Primary sponsor

Full Name
The University Of Birmingham
Organisation Type
Educational Institution
Country Of Registered Address
United Kingdom

Third parties

  • {"country":"Czechia","full_name":"Proton Therapy Center Czech, s.r.o.","duties_or_roles":"Proton Therapy","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Bonn AöR","duties_or_roles":"Quality of Survival","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Czechia","full_name":"Masarykuv Onkologicky Ustav","duties_or_roles":"Radiotherapy","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Great Ormond Street Hospital","duties_or_roles":"Medical image analysis/review","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Norway","full_name":"Sykehusapoteket Oslo","duties_or_roles":"Drug Accountability","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"University Of Southampton","duties_or_roles":"Quality of Survival","organisation_type":"Educational Institution"}
  • {"country":"Netherlands","full_name":"Julius Clinical International B.V.","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"St. Anna Kinderspital GmbH","duties_or_roles":"High Dose Chemotherapy","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Czechia","full_name":"Masarykova Univerzita","duties_or_roles":"12","organisation_type":"Educational Institution"}
  • {"country":"United Kingdom","full_name":"Royal Victoria Infirmary","duties_or_roles":"Medical image analysis/review","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Aarhus Universitetshospital","duties_or_roles":"Radiotherapy","organisation_type":"Health care"}
  • {"country":"Austria","full_name":"Medical University Of Vienna","duties_or_roles":"National Reference Centre for Histopathology, molecular diagnostics and CSF diagnostics (Austria)","organisation_type":"Educational Institution"}
  • {"country":"United Kingdom","full_name":"Newcastle University Centre for Cancer","duties_or_roles":"Molecular diagnostics, Histopathology, International Reference Centre","organisation_type":"Educational Institution"}
  • {"country":"Italy","full_name":"Associazione Italiana Ematologia Oncologia Pediatrica","duties_or_roles":"5","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Universitaet Muenster","duties_or_roles":"1","organisation_type":"Educational Institution"}
  • {"country":"Austria","full_name":"Competence In Scientific Services Eggenreich & Gschanes GmbH","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Augsburg","duties_or_roles":"Medical image analysis/review","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Vis Ethic Research S.r.l.","duties_or_roles":"1; 9","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"St. Anna Kinderspital GmbH (duplicate record)","duties_or_roles":"High Dose Chemotherapy","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Czechia","full_name":"Masarykova Univerzita (duplicate record)","duties_or_roles":"12","organisation_type":"Educational Institution"}
  • {"country":"Norway","full_name":"Sykehusapoteket Oslo (duplicate record)","duties_or_roles":"Drug Accountability","organisation_type":"Health care"}
  • {"country":"Belgium","full_name":"QUARTET","duties_or_roles":"Radiotherapy Quality Assurance/ Quality control","organisation_type":"Educational Institution"}
  • {"country":"United Kingdom","full_name":"Alder Hey Children's Hospital","duties_or_roles":"Medical image analysis/ review","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Westdeutsches Protonentherapiezentrum Essen (WPE) gGmbH","duties_or_roles":"Radiotherapy","organisation_type":"Health care"}
  • {"country":"Italy","full_name":"Vis Ethic Research S.r.l. (duplicate record)","duties_or_roles":"1; 9","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"Radiotherapy Quality Assurance/ Quality control","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Austria","full_name":"Competence In Scientific Services Eggenreich & Gschanes GmbH (duplicate)","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"","full_name":"Universitaetsklinikum WPE/other (other duplicates omitted)","duties_or_roles":"","organisation_type":"Various"}

Investigational products

Investigational Product Name
TEMOZOLOMIDE
Active Substance
TEMOZOLOMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
150 mg/m2
Investigational Product Name
VINCRISTINE SULFATE
Active Substance
VINCRISTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
2 mg/m2
Investigational Product Name
Lomustine caps 10 mg
Active Substance
LOMUSTINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Maximum Dose
75 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
70 mg/m2
Investigational Product Name
THIOTEPA
Active Substance
THIOTEPA
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
200 mg/m2
Investigational Product Name
LOMUSTINE
Active Substance
LOMUSTINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
75 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
400 mg/m2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
1000 mg/m2
Combination Treatment
Yes

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