HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

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.

Principal Investigator:
Plant, Ashley MD

Research Coordinator:
Tina Templeman
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 170767
  • Sponsor: NEXT Consortium
  • Protocol Number: Head Start IV
  • NCT Number: NCT02875314
  • Research Type: Brain Tumor/Central Nervous System/Neuro-Oncology
  • Phase: III
  • Status: Active