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NCT02875314 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Medulloblastoma and Central Nervous System Embryonal Tumors, sponsored by Parth Patel.

Active
Registry status
Phase 4
Development phase
250
Enrollment target
20
Study locations

NCT02875314: Active Phase 4 study of Medulloblastoma and Central Nervous System Embryonal Tumors, sponsored by Parth Patel.

NCT02875314 is a Phase 4 study of Medulloblastoma and Central Nervous System Embryonal Tumors that is active but no longer recruiting, run by Parth Patel. The registered enrollment target is 250 participants, above the 132-participant average among 29 other Medulloblastoma trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02875314, a Phase 4 study of Medulloblastoma and Central Nervous System Embryonal Tumors, is active but no longer recruiting, sponsored by Parth Patel.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
250 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Dose-intensive tandem Consolidation will be compared with single cycle consolidation via randomization. The randomized consolidations will provide an event-free survival (EFS) analysis after completing "Head Start 4" Induction.

Conditions Studied

Medulloblastoma Central Nervous System Embryonal Tumors

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

FieldValue
Enrollment Target 250 participants
Start Date 2015-09
Est. Completion 2030-12
Phase Phase 4
Parth Patel

1 total trials

What the registry record for NCT02875314 still lists

NCT02875314 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 29 other Medulloblastoma trials with a reported enrollment target (89% higher).

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.

NCT02875314 names 20 study sites across 11 states, led by California, Florida, Alabama.

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.

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).

Who is sponsoring clinical trial NCT02875314?

This trial is sponsored by Parth Patel, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Medulloblastoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02875314's enrollment target sits among peer trials

250 5th of 29 higher than 25 of 29 other Medulloblastoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Medulloblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02875314, the US trial registry maintained by the National Library of Medicine. NCT02875314 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.