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Clinical trialNCT05382338RecruitingPhase 3Interventional

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

SponsorChildren's Oncology GroupEnrollment225Childhood Medulloblastoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

108 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Iwk Health Centre

    Halifax, Nova Scotia, Canada

    Chelsea Ash
    Recruiting
  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, Canada

    Monia Marzouki
    Recruiting
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, Canada

    Josee Brossard
    Recruiting
  • Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)

    Québec, Canada

    Bruno Michon
    Recruiting
United States
  • Children'S Hospital of Alabama

    Birmingham, Alabama, United States

    Active, not recruiting
  • Usa Health Strada Patient Care Center

    Mobile, Alabama, United States

    Hamayun Imran
    Recruiting
  • Phoenix Childrens Hospital

    Phoenix, Arizona, United States

    Michael R. Mangum
    Recruiting
  • Arkansas Children'S Hospital

    Little Rock, Arkansas, United States

    Michael W. Bishop
    Recruiting
  • Loma Linda University Medical Center

    Loma Linda, California, United States

    Albert Kheradpour
    Recruiting
  • Miller Children'S and Women'S Hospital Long Beach

    Long Beach, California, United States

    Jacqueline N. Casillas
    Recruiting
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

    Ashley S. Margol
    Recruiting
  • Valley Children'S Hospital

    Madera, California, United States

    Ruetima Titapiwatanakun
    Recruiting
  • Kaiser Permanente-Oakland

    Oakland, California, United States

    Aarati V. Rao
    Recruiting
  • Children'S Hospital of Orange County

    Orange, California, United States

    Elyssa M. Rubin
    Recruiting
  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Marcio H. Malogolowkin
    Recruiting
  • Rady Children'S Hospital - San Diego

    San Diego, California, United States

    William D. Roberts
    Recruiting
  • Ucsf Medical Center-Mission Bay

    San Francisco, California, United States

    Alyssa T. Reddy
    Recruiting
  • Children'S Hospital Colorado

    Aurora, Colorado, United States

    Holly B. Lindsay
    Recruiting
  • Connecticut Children'S Medical Center

    Hartford, Connecticut, United States

    Michael S. Isakoff
    Recruiting
  • Yale University

    New Haven, Connecticut, United States

    Asher M. Marks
    Recruiting
  • Alfred I Dupont Hospital for Children

    Wilmington, Delaware, United States

    Sridhi Patel
    Recruiting
  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

    Jeffrey S. Dome
    Recruiting
  • Golisano Children'S Hospital of Southwest Florida

    Fort Myers, Florida, United States

    Emad K. Salman
    Recruiting
  • Memorial Regional Hospital/joe Dimaggio Children'S Hospital

    Hollywood, Florida, United States

    Iftikhar Hanif
    Recruiting
  • Nemours Children'S Clinic-Jacksonville

    Jacksonville, Florida, United States

    Sridhi Patel
    Recruiting
  • Nicklaus Children'S Hospital

    Miami, Florida, United States

    Ziad A. Khatib
    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, United States

    Bradley Gampel
    Recruiting
  • Arnold Palmer Hospital for Children

    Orlando, Florida, United States

    Jaime M. Libes-Bander
    Recruiting
  • Nemours Children'S Hospital

    Orlando, Florida, United States

    Sridhi Patel
    Recruiting
  • Nemours Children'S Clinic - Pensacola

    Pensacola, Florida, United States

    Jeffrey H. Schwartz
    Recruiting
  • Saint Joseph'S Hospital/children'S Hospital-Tampa

    Tampa, Florida, United States

    Don E. Eslin
    Recruiting
  • Children'S Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, United States

    Anna J. Janss
    Recruiting
  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, United States

    Wade T. Kyono
    Recruiting
  • University of Illinois

    Chicago, Illinois, United States

    Dipti S. Dighe
    Recruiting
  • Osf Children'S Hospital of Illinois

    Peoria, Illinois, United States

    Prerna Kumar
    Recruiting
  • Southern Illinois University School of Medicine

    Springfield, Illinois, United States

    Gregory P. Brandt
    Recruiting
  • Riley Hospital for Children

    Indianapolis, Indiana, United States

    Sandeep Batra
    Recruiting
  • Blank Children'S Hospital

    Des Moines, Iowa, United States

    Samantha L. Mallory
    Recruiting
  • University of Iowa/holden Comprehensive Cancer Center

    Iowa City, Iowa, United States

    Andrew P. Groves
    Recruiting
  • Norton Children'S Hospital

    Louisville, Kentucky, United States

    Michael J. Ferguson
    Recruiting
68 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Feb 2023
Primary completion
31 Dec 2029
Completion
31 Dec 2029
Last update posted
16 Jul 2026
Registered enrollment
225
Registry id
NCT05382338

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.