Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04939597 · ClinicalTrials.gov registry record · Phase 3
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor
A Phase 3 study of Central Nervous System Carcinoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT04939597: Active Phase 3 study of Central Nervous System Carcinoma, sponsored by Children's Oncology Group.
NCT04939597 is a Phase 3 study of Central Nervous System Carcinoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 192 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04939597, a Phase 3 study of Central Nervous System Carcinoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
Primary Outcome
Estimate the difference in mean Cogstate composite Z score slopes (reflecting change in Cogstate composite Z scores from baseline to 12 months post baseline taking into account measurements at those time points as well as end of radiation therapy and 3 and 6-months post baseline) between the treatment and control arms using a generalized estimating equation model with compound symmetry correlation structure. Will provide a point estimate and corresponding 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Cognitive Assessment
- DRUG Placebo Administration
- DRUG Memantine Hydrochloride
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What the registry record for NCT04939597 still lists
NCT04939597 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Central Nervous System Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04939597 names 20 study sites across 7 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04939597 about?
NCT04939597 is a clinical study titled "A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor". This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (...
What is the current status of trial NCT04939597?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2022-05-10. Estimated completion is 2027-09-30.
What conditions does trial NCT04939597 study?
This clinical trial studies the following conditions: Central Nervous System Carcinoma.
What interventions are being tested in trial NCT04939597?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cognitive Assessment (PROCEDURE), Placebo Administration (DRUG), Memantine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04939597?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04939597 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Central Nervous System Carcinoma
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 NCT04939597's enrollment target sits among peer trials
192 1398th of 2000 higher than 599 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492972 · 192 participants · Phase 3
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
- NCT01973881 · 192 participants
Quantitative MRI for Myelofibrosis
- NCT02535702 · 192 participants · NA
Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction
- NCT03622359 · 192 participants · NA
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI