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)

Beteiligte Wissenschaftler und Funktion

Statistische Planung und statistische Auswertung (PNET 5 MB - SR)
Univ.-Prof. Dr. rer. nat. et med. habil. Andreas Faldum
Dr. rer. nat. Robert Kwiecien

Studienleitung
Prof. Dr. Stefan Rutkowski, University Medical Center Hamburg-Eppendorf (UKE)
Prof. François Doz, Paris Descartes University, Institut Curie

Förderung
Deutsche Kinderkrebsstiftung

Ziel der Studie
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively.
The primary objective of SIOP - PNET 5 MB - SR is 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.