NCT05382338|RecruitingPhase 3FDA Drug

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

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

Children's Oncology Group ClinicalTrials.gov

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3 other identifiers

ACNS2031NCI-2022-04866U10CA180886

Study Type

interventional

Target

225

Locations

2 countries

Sites

105

Timeline

RegisteredMay 2022

StartedFeb 2023

CompletionDec 2029

Brief 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 without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

225

participants targeted

Target at P25-P50 for phase_3

Timeline

45mo left

Started Feb 2023

Longer than P75 for phase_3

Geographic Reach

2 countries

105 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.9 years study duration

Study Progress47%

Feb 2023Dec 2029

First Submitted

Initial submission to the registry

April 15, 2022

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed

9 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed

6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 5, 2026

Status Verified

February 1, 2026

Enrollment Period

6.9 years

First QC Date

April 15, 2022

Last Update Submit

May 1, 2026

Conditions

Childhood Medulloblastoma

Outcome Measures

Primary Outcomes (2)

Percentage of patients with >= grade 2 hearing loss
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.
At 4 weeks after the last dose of cisplatin
Event-free survival (EFS)
Will estimate the EFS distribution using Kaplan-Meier (KM) method.
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

Secondary Outcomes (10)

Overall survival (OS)
Up to 10 years
Incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort
Up to 10 years
Incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts
Up to 10 years
Full scale intelligence neurocognitive outcomes and trajectories of patients with average-risk medulloblastoma treated with sodium thiosulfate (STS)
Up to 5 years
Quality of life and psychosocial outcomes of patients with average-risk medulloblastoma treated with STS
Up to 5 years
+5 more secondary outcomes

Other Outcomes (7)

Paired blood and tumor tissue banking or future studies
Up to 5 years
Blood and cerebrospinal fluid banking for future studies
Up to 5 years
Attention, processing speed, memory, and executive function neurocognitive outcomes and trajectories of patients with average-risk medulloblastoma treated with STS
Up to 5 years
+4 more other outcomes

Study Arms (1)

Treatment (chemoradiotherapy, maintenance)

EXPERIMENTAL

See Detailed Description.

Procedure: Audiometric TestProcedure: Auditory Brainstem ResponseProcedure: Biospecimen CollectionDrug: CisplatinDrug: CyclophosphamideDrug: LomustineProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentRadiation: Radiation TherapyDrug: Sodium ThiosulfateOther: Survey AdministrationDrug: Vincristine

Interventions

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI