Nationwide Children's Hospital
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).
In this study, two highly effective irradiation-sparing treatment regimens are being compared in patients with low-risk early childhood MB: 1. Arm A: The "Head Start" 4 regimen developed by the North American Head Start Consortium. This approach uses intensive Induction chemotherapy and Consolidation with HDCT and has led to equally favorable results in this subgroup -- 3y PFS was 96% for infants and young children with M0, SHH MB; 5y EFS was 93% for M0, DMB on the predecessor "Head Start" 3 study. 2. Arm B: The HIT-SKK regimen developed within the GPOH. This regimen combines systemic chemoth…
Inclusion Criteria for screening: * 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 * Patient and the parents/legal representative are able and willing to participate in the entire study (if patient is eligible) Exclusion Criteria for overall study: * Patients previously treated f…
One bridging chemotherapy cycle consists of five days of therapy using Carboplatin and etoposide
Cisplatin, vincristin, etoposide, cyclophosphamide, high-dose methotrexate
Cisplatin, etoposide, cyclophosphamide, high-dose methotrexate
Carboplatin, thiotepa, etoposide
Cyclophosphamide, vincristine, high-dose methotrexate, carboplatin, etoposide, i.ventri. methotrexate
Cyclophosphamide, vincristine, carboplatin, etoposide
Arctuva estimate
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