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

NCT02875314 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Induction

vincristine, cisplatin, cyclophosphamide, etoposide, high-dose methotrexate

DRUG

Single Cycle Intensive Chemotherapy

Carboplatin, thiotepa, etoposide

DRUG

Tandem 3 Cycle Intensive Chemotherapy

Carboplatin, thiotepa

Sponsors & Collaborators

  • Children's of Alabama

    collaborator OTHER

  • Parth Patel

    lead OTHER

Principal Investigators

  • Randal Olshefski, MD · Nationwide Children's Hospital

  • Jonathan Finlay, MD · Global Neuro-Oncology, Inc.

  • Girish Dhall, MD · Children's of Alabama at UAB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875314 on ClinicalTrials.gov