HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
Public ClinicalTrials.gov record NCT02875314. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02875314
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 250 participants
Conditions and interventions
Interventions
Drug
Eligibility (public fields only)
- Age range
- Up to 10 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Actual)
- Primary completion
- Dec 2030 (Estimated)
- Completion
- Dec 2030 (Estimated)
- Last update posted
- Jun 3, 2026
2015 – 2030
United States locations
- U.S. sites
- 55
- U.S. states
- 29
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92350 | — |
| Memorial Care Health Services | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Mattel Children's Hospital (UCLA) | Los Angeles | California | 90095 | — |
| UCSF Oakland Benioff | Oakland | California | 94609 | — |
| Children's Hospital Orange County | Orange | California | 91868 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Center for Cancer and Blood Disorders | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands Children's Hospital/ University of FL | Gainesville | Florida | 32608 | — |
| Nemours Center for Cancer and Blood Disorders | Jacksonville | Florida | 19803 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| John's Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | — |
| Riley Children's Hospital/University of Indiana | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| University of Louisville School of Medicine | Louisville | Kentucky | 40202 | — |
| John's Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Central Michigan University | Detroit | Michigan | 48201 | — |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Children's Hospital of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Masonic Children's Hospital/University of Minnesota | Minneapolis | Minnesota | 55454 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Children's Specialty Care of Nevada | Las Vegas | Nevada | 89135 | — |
| Joseph Sanzari Children's Hospital/ Hackensack University | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center, Atlantic Health System | Morristown | New Jersey | 07960 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| Northwell Health | Hempstead | New York | 11549 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Columbia Presbyterian Children's Hospital | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Upstate Golisano Children's Hospital/ SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Carolina's HealthCare System/Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| American Family Children's Hospital/University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 58226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02875314, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02875314 live on ClinicalTrials.gov.