A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
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.
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
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- Audiometric Test Procedure
- Auditory Brainstem Response Procedure
- Biospecimen Collection Procedure
- Cisplatin Drug
- Cyclophosphamide Drug
- Lomustine Drug
- Magnetic Resonance Imaging Procedure
- Quality-of-Life Assessment Other
- Radiation Therapy Radiation
- Sodium Thiosulfate Drug
- Survey Administration Other
- Vincristine Drug
Procedure · Drug · Other + 1 more
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
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05382338 live on ClinicalTrials.gov.