HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
This is a prospective randomized clinical trial, to determine whether dose-intensive tandem
Consolidation, in a randomized comparison with single cycle Consolidation, provides an
event-free survival (EFS) and overall survival (OS). The study population will be high-risk
patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with
central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study
will further determine whether the additional labor intensity (duration of hospitalizations
and short-term and long-term morbidities) associated with the tandem treatment is justified
by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation
regimen will produce a superior outcome compared to the single cycle Consolidation, given the
substantially higher dose intensity of the tandem regimen, without significant addition of
either short-term or long-term morbidities.
Phase:
Phase 4
Details
Lead Sponsor:
Nationwide Children's Hospital
Collaborators:
Children's Hospital Los Angeles Children's of Alabama