A clinical trial program to optimize the surgical approach and risk-stratified radio/chemotherapy in clinically standard risk or WNT-activated medulloblastoma of childhood and young adult patients eligible for craniospinal radiotherapy


Beteiligte Wissenschaftler und Funktion

Statistische Planung und statistische Auswertung
Dr. rer. nat. Robert Kwiecien

Studienleitung
Prof. Dr. med. Martin Mynarek, University Medical Center Hamburg-Eppendorf (UKE) 
Prof. Dr. med. Till Milde, Jena University Hospital (UKJ) 
Prof. François Doz, Paris Descartes University, Institut Curie

Förderung
Deutsche Kinderkrebsstiftung

Ziel der Studie
-To investigate whether a surgery aiming at subtotal safe tumor resection leads to better processing speed outcomes compared to maximal safe surgical tumor resection.
-To investigate whether 3-year progression-free survival in WNT-activated, clinically standard-risk medulloblastoma patients treated with 14.4 Gy craniospinal irradiation (CSI) and 4 cycles of maintenance chemotherapy (cyclophosphamide and vincristine) is non-inferior to 90%.
- To investigate whether 3-year progression-free survival in biologically low-risk and clinically standard-risk medulloblastoma patients treated with 18Gy CSI and 3 cycles of maintenance-chemotherapy (cisplatin, vincristine and cyclophosphamide) is non-inferior to 90%.

- To investigate whether progression-free survival in biologically high-risk and clinically standard-risk medulloblastoma patients (Standard-risk; SR) treated with tandem high-dose chemotherapy (thiotepa), 23.4 Gy CSI and maintenance chemotherapy (temozolomide) is superior to progression-free survival observed in patients with the same diagnosis, treated with 23.4 Gy CSI and 4 cycles of maintenance chemotherapy (cisplatin, cyclophosphamide and vincristine).

- To assess progression-free survival rates in patients

a) with WNT-activated medulloblastoma and clinically high-risk factors
b) with WNT-activated medulloblastoma and radiologically subtotal resection (STRRad; residual tumor ≥1.5cm2) after induction chemotherapy and potential second tumor surgery 
c) with biologically favourable-risk medulloblastoma (SHH-TP53wt MB or non-WNT/non-SHH MB with favourable risk markers) and STRRad after induction chemotherapy and potential second tumor surgery as the only risk-factor.