This is a trial to compare neurocognitive outcomes in the intent-to-treat population 2.5 years after diagnosis between patients with newly diagnosed, non-metastatic, SHH-activated, TP53-wt, non-MYC amplified MF randomized to the interventional arms A ("Head Start 4") or B (HIT-SKK).
Age at diagnosis < 5 years
Patients with institutional suspicion or diagnosis of SHH-activated MB
Patient and family in social circumstances that will allow neuropsychological follow-up
Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures
Patients previously treated for any other brain tumor or any type of malignant disease
Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured
History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product.
Patients/parents who do not wish to abstain from treatment with live vaccines during study participation
Nationwide Children's Hospital
Lead sponsor
German Society of Paediatric Oncology and Hematology (GPOH gGmbH)
Collaborator
Children's of Alabama
Collaborator