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NCT05382338 · ClinicalTrials.gov registry record · Phase 3
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
A Phase 3 study of Childhood Medulloblastoma, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT05382338: Recruiting Phase 3 study of Childhood Medulloblastoma, sponsored by Children's Oncology Group.
NCT05382338 is a Phase 3 study of Childhood Medulloblastoma that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05382338, a Phase 3 study of Childhood Medulloblastoma, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Will estimate the number and percentage of patients with \>= grade 2 hearing loss using the society of pediatric oncology (SIOP) scale (defined as hearing threshold \>20 dB at \>= 4kHz) 4 weeks after the last dose of cisplatin. If hearing loss is observed in both ears, the worse ear will be used for this primary analysis.
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 |
What NCT05382338 shows while recruiting
NCT05382338 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (71% lower).
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.
NCT05382338 names 20 study sites across 9 states, led by California, Florida, Alabama.
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.
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).
Who is sponsoring clinical trial NCT05382338?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT05382338's enrollment target sits among peer trials
225 1312th of 2000 higher than 684 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
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