SIOP PNET 5 MB
Author: Julia Dobke, Last modification: 2024/04/19 https://kinderkrebsinfo.de/doi/e139261
SIOP PNET 5 MB | AN INTERNATIONAL PROSPECTIVE STUDY ON CLINICALLY STANDARD-RISK MEDULLOBLASTOMA IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH LOW-RISK BIOLOGICAL PROFILE (PNET 5 MB - LR) OR AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR) |
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Disease | Standard-Risk Medulloblastoma |
Type | International, prospective, Phase-II trial |
Rationale / Objectives |
Primary objective LR-group
To confirm that the 3-year Event-Free Survival (EFS) rate in children and adolescents with standard-risk medulloblastoma having a low-risk biological profile remains in excess of 80% when patients are treated with 23.4 Gy neuraxis irradiation plus boost to the primary tumor, and reduced-intensity chemotherapy.
Primary objective SR-group
To test whether the Event-Free Survival (EFS) in children and adolescents with standard-risk medulloblastoma having an average-risk biological profile is different for patients treated with or without carboplatin concomitantly with radiotherapy (23.4 Gy neuraxis irradiation plus boost to the primary tumor) followed by a modified maintenance chemotherapy.
Primäre Fragestellung WNT-HR
Primäre Fragestellung SHH-TP53
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Therapy / Study arms |
Low-risk-group (LR)
Radiotherapy:
Chemotherapy:
Standard-risk-group (SR)
Radiotherapy:
Chemotherapy:
WNT-HR (HR):
Radiotherapy:
Chemotherapie:
SHH-TP53 (HR):
Chemotherapie:
Strahlentherapie (mit wöchentlichem VCR 1,5mg/m2):
PNET5-Register
Registerziele: |
Inclusion Criteria |
|
Exclusion Criteria |
|
Status | Recruitment ic closed since 06.04.2022, only open for follow-up |
EudraCT | 2011-004868-30 |
Entry Study Register | |
Principal Investigator | Prof. Dr. med. Stefan Rutkowski |
hitchem@uke.de | |
URL | https://www.uke.de/kliniken-institute/kliniken/p%C3%A4diatrische-h%C3%A4matologie-und-onkologie/forschung/arbeitsgruppen/hit-studien.html |
Contact |
Coordinating investigatorProf. Dr. med. Stefan Rutkowski Universitätsklinikum Hamburg-Eppendorf Klinik u. Poliklinik f. Päd. Onkologie u. Hämatologie, Haus N21 Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410 58200 Fax +49 (40) 7410 58300 s.rutkowski@uke.de Co-coordinating investigatorDr. med. Katja von Hoff Universitätsklinikum Aarhus cns-interrest@charite.de Study CoordinatorPD Dr. med. Martin Mynarek Universitätsklinikum Hamburg-Eppendorf Klinik für Pädiatrische Hämatologie und Onkologie Martinistr. 52 20246 Hamburg Telefon +49 (0)40 74 10-5 33 94 m.mynarek@uke.de Data managementSusanne Becker Universitätsklinikum Hamburg-Eppendorf Klinik u. Poliklinik f. Päd. Onkologie u. Hämatologie, Haus N21, HIT-MED Studienzentrale Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410 58200 Fax +49 (40) 7410 58300 hitchem@uke.de Antje Stiegmann Universitätsklinikum Hamburg-Eppendorf Klinik u. Poliklinik f. Päd. Onkologie u. Hämatologie, Haus N21, HIT-MED Studienzentrale Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410 58200 Fax +49 (40) 7410 58300 hitchem@uke.de |
Participants | Austria, Belgium, Czech, Denmark, France, Germany, Irland, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netheralns, United Kingdom |
Weitere Informationen | Amendment 2018, version 12 |
Link(s) | Publications on Medullobaslatomas |
Sponsoring | Deutsche Kinderkrebsstiftung |