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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors
NCT02875314 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Induction
- DRUG Single Cycle Intensive Chemotherapy
- DRUG Tandem 3 Cycle Intensive Chemotherapy
Study Locations (20)
California
- Loma Linda University Medical Center — Loma Linda
- Memorial Care Health Services — Long Beach
- Children's Hospital Los Angeles — Los Angeles
- Mattel Children's Hospital (UCLA) — Los Angeles
- UCSF Oakland Benioff — Oakland
- Children's Hospital Orange County — Orange
Florida
- Shands Children's Hospital/ University of FL — Gainesville
- Nemours Center for Cancer and Blood Disorders — Jacksonville
- Nicklaus Children's Hospital — Miami
- Orlando Health — Orlando
- John's Hopkins All Children's Hospital — St. Petersburg
Alabama
- Children's of Alabama — Birmingham
Arizona
- Phoenix Children's Hospital — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital Colorado — Aurora
Delaware
- Nemours Center for Cancer and Blood Disorders — Wilmington
District of Columbia
- Children's National Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2015-09 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02875314
The ClinicalTrials.gov registry entry for NCT02875314 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Parth Patel, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Medulloblastoma appearing as the primary indexed condition, and to 3 interventions — of which Induction is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02875314 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02875314 about?
NCT02875314 is a clinical study titled "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...
What is the current status of trial NCT02875314?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2015-09. Estimated completion is 2030-12.
What conditions does trial NCT02875314 study?
This clinical trial studies the following conditions: Medulloblastoma, Central Nervous System Embryonal Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02875314?
The interventions under investigation include: Induction (DRUG), Single Cycle Intensive Chemotherapy (DRUG), Tandem 3 Cycle Intensive Chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02875314?
This trial is sponsored by Parth Patel, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02875314 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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