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Recruiting Phase 3 Interventional

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

ClinicalTrials.gov ID: NCT05382338

Public ClinicalTrials.gov record NCT05382338. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.

Study identification

NCT ID
NCT05382338
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
225 participants

Conditions and interventions

Eligibility (public fields only)

Age range
4 Years to 21 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
Feb 19, 2023
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029
Last update posted
Aug 24, 2026

2023 – 2029

United States locations

U.S. sites
106
U.S. states
39
U.S. cities
95
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 Active, not recruiting
USA Health Strada Patient Care Center Mobile Alabama 36604 Recruiting
Phoenix Childrens Hospital Phoenix Arizona 85016 Recruiting
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 Recruiting
Loma Linda University Medical Center Loma Linda California 92354 Recruiting
Miller Children's and Women's Hospital Long Beach Long Beach California 90806 Recruiting
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
Valley Children's Hospital Madera California 93636 Recruiting
Kaiser Permanente-Oakland Oakland California 94611 Recruiting
Children's Hospital of Orange County Orange California 92868 Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
Rady Children's Hospital - San Diego San Diego California 92123 Recruiting
UCSF Medical Center-Mission Bay San Francisco California 94158 Recruiting
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Yale University New Haven Connecticut 06520 Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware 19803 Recruiting
Children's National Medical Center Washington D.C. District of Columbia 20010 Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021 Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 Recruiting
Nicklaus Children's Hospital Miami Florida 33155 Recruiting
Arnold Palmer Hospital for Children Orlando Florida 32806 Recruiting
Nemours Children's Hospital Orlando Florida 32827 Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 Recruiting
University of Illinois Chicago Illinois 60612 Recruiting
OSF Children's Hospital of Illinois Peoria Illinois 61637 Recruiting
Southern Illinois University School of Medicine Springfield Illinois 62702 Recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Blank Children's Hospital Des Moines Iowa 50309 Recruiting
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 Recruiting
Norton Children's Hospital Louisville Kentucky 40202 Recruiting
Children's Hospital New Orleans New Orleans Louisiana 70118 Recruiting
Sinai Hospital of Baltimore Baltimore Maryland 21215 Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 Recruiting
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114 Suspended
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
C S Mott Children's Hospital Ann Arbor Michigan 48109 Recruiting
Children's Hospital of Michigan Detroit Michigan 48201 Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 Recruiting
Corewell Health Children's Royal Oak Michigan 48073 Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 Recruiting
Mayo Clinic in Rochester Rochester Minnesota 55905 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 Recruiting
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 Recruiting
University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
Saint Peter's University Hospital New Brunswick New Jersey 08901 Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 Recruiting
Newark Beth Israel Medical Center Newark New Jersey 07112 Recruiting
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 Recruiting
Albany Medical Center Albany New York 12208 Recruiting
Roswell Park Cancer Institute Buffalo New York 14263 Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040 Suspended
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 Recruiting
Mount Sinai Hospital New York New York 10029 Recruiting
Stony Brook University Medical Center Stony Brook New York 11794 Recruiting
State University of New York Upstate Medical University Syracuse New York 13210 Recruiting
Montefiore Medical Center - Moses Campus The Bronx New York 10467 Recruiting
New York Medical College Valhalla New York 10595 Recruiting
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 Recruiting
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 Recruiting
East Carolina University Greenville North Carolina 27834 Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting
Sanford Broadway Medical Center Fargo North Dakota 58122 Recruiting
Children's Hospital Medical Center of Akron Akron Ohio 44308 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Dayton Children's Hospital Dayton Ohio 45404 Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Recruiting
Legacy Emanuel Children's Hospital Portland Oregon 97227 Recruiting
Oregon Health and Science University Portland Oregon 97239 Recruiting
Geisinger Medical Center Danville Pennsylvania 17822 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 Recruiting
Rhode Island Hospital Providence Rhode Island 02903 Recruiting
Prisma Health Richland Hospital Columbia South Carolina 29203 Recruiting
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 Recruiting
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 Recruiting
East Tennessee Childrens Hospital Knoxville Tennessee 37916 Recruiting
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 Suspended
Dell Children's Medical Center of Central Texas Austin Texas 78723 Recruiting
Driscoll Children's Hospital Corpus Christi Texas 78411 Recruiting
Medical City Dallas Hospital Dallas Texas 75230 Recruiting
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 Recruiting
El Paso Children's Hospital El Paso Texas 79905 Recruiting
Children's Hospital of San Antonio San Antonio Texas 78207 Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 Recruiting
University of Virginia Cancer Center Charlottesville Virginia 22908 Recruiting
Children's Hospital of The King's Daughters Norfolk Virginia 23507 Recruiting
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 Recruiting
Seattle Children's Hospital Seattle Washington 98105 Recruiting
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 Recruiting
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Recruiting
Marshfield Medical Center-Marshfield Marshfield Wisconsin 54449 Recruiting
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 Recruiting

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 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05382338, 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 Aug 24, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05382338 live on ClinicalTrials.gov.

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