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A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
NCT05382338 · View on ClinicalTrials.gov ↗
Study Summary
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 witho
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- DRUG Cisplatin
- PROCEDURE Audiometric Test
- PROCEDURE Auditory Brainstem Response
Study Locations (20)
California
- 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
- Kaiser Permanente-Oakland — Oakland
- Children's Hospital of Orange County — Orange
- Rady Children's Hospital - San Diego — San Diego
- UCSF Medical Center-Mission Bay — San Francisco
Florida
- Golisano Children's Hospital of Southwest Florida — Fort Myers
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood
- Nemours Children's Clinic-Jacksonville — Jacksonville
Alabama
- Children's Hospital of Alabama — Birmingham
- USA Health Strada Patient Care Center — Mobile
Connecticut
- Connecticut Children's Medical Center — Hartford
- Yale University — New Haven
Arizona
- Phoenix Childrens Hospital — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital Colorado — Aurora
Delaware
- Alfred I duPont Hospital for Children — Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05382338
The ClinicalTrials.gov registry entry for NCT05382338 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Childhood Medulloblastoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05382338 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05382338 about?
NCT05382338 is a clinical study titled "A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss". 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 typic...
What is the current status of trial NCT05382338?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2023-02-20. Estimated completion is 2029-12-31.
What conditions does trial NCT05382338 study?
This clinical trial studies the following conditions: Childhood Medulloblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05382338?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Cisplatin (DRUG), Audiometric Test (PROCEDURE), Auditory Brainstem Response (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05382338?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05382338 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.
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