NCT05382338 · Children's Oncology Group
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Audiometric Test
Ancillary studies
PROCEDURE
Auditory Brainstem Response
Ancillary studies
PROCEDURE
Biospecimen Collection
Undergo CSF and blood sample collection
DRUG
Cisplatin
Given IV
DRUG
Cyclophosphamide
Given IV
DRUG
Lomustine
Given PO
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
OTHER
Quality-of-Life Assessment
Ancillary studies
RADIATION
Radiation Therapy
Undergo radiation therapy
DRUG
Sodium Thiosulfate
Given IV
OTHER
Survey Administration
Ancillary studies
DRUG
Vincristine
Given IV
Primary outcome measures
Percentage of patients with >= grade 2 hearing loss
Time frame: At 4 weeks after the last dose of cisplatin
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.
Event-free survival (EFS)
Time frame: From initiation of the protocol treatment to the occurrence of disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 10 years
Will estimate the EFS distribution using Kaplan-Meier (KM) method.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment
- PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis
- Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening
- PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)
- PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery
- PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis crite
Where
- Birmingham, Alabama
- Mobile, Alabama
- Phoenix, Arizona
- Little Rock, Arkansas
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Madera, California
- Oakland, California
- Orange, California
- Sacramento, California
- San Diego, California
And 81 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations