Clinical trialNCT02875314Active, not recruitingPhase 4Interventional

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

SponsorParth PatelEnrollment250Central Nervous System Embryonal TumorsMedulloblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Girish Dhall, MD
Children's of Alabama at UAB
Study Chair
clinicaltrials.gov ↗
Jonathan Finlay, MD
Global Neuro-Oncology, Inc.
Study Chair
clinicaltrials.gov ↗
Randal Olshefski, MD
Nationwide Children's Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

62 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

B.C. Children'S Hospital
Vancouver, British Columbia, Canada
Alberta Children'S Hospital
Calgary, Canada
Stollery Children'S Hospital
Edmonton, Canada
Hamilton Health/mcmasters Children'S Hospital, Hamilton, Canada
Hamilton, Canada
the Hospital of Sick Children
Toronto, Canada

New Zealand

Starship Children'S Hospital
Auckland, New Zealand
Christchurch Children'S Hospital
Christchurch, New Zealand

United States

Children'S of Alabama
Birmingham, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Memorial Care Health Services
Long Beach, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Mattel Children'S Hospital (ucla)
Los Angeles, California, United States
Ucsf Oakland Benioff
Oakland, California, United States
Children'S Hospital Orange County
Orange, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Nemours Center for Cancer and Blood Disorders
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Shands Children'S Hospital/ University of Fl
Gainesville, Florida, United States
Nemours Center for Cancer and Blood Disorders
Jacksonville, Florida, United States
Nicklaus Children'S Hospital
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
John'S Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Children'S Hospital/university of Indiana
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Louisville School of Medicine
Louisville, Kentucky, United States
John'S Hopkins University School of Medicine
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Central Michigan University
Detroit, Michigan, United States
Helen Devos Children'S Hospital
Grand Rapids, Michigan, United States
Children'S Hospital of Minnesota
Minneapolis, Minnesota, United States
Masonic Children'S Hospital/university of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Children'S Specialty Care of Nevada
Las Vegas, Nevada, United States
Joseph Sanzari Children'S Hospital/ Hackensack University
Hackensack, New Jersey, United States
Morristown Medical Center, Atlantic Health System
Morristown, New Jersey, United States

22 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

InductionSingle Cycle Intensive ChemotherapyTandem 3 Cycle Intensive Chemotherapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Sept 2015
Primary completion: 31 Dec 2030
Completion: 31 Dec 2030
Last update posted: 3 Jun 2026
Registered enrollment: 250
Registry id: NCT02875314

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.