Clinical trial · Observational
Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated. Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ototoxicity | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Stereotactic radiosurgery group
- description
- Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study.
- interventionNames
- Radiation: Stereotactic radiosurgery
- label
- Wait and scan group
- description
- Patients with unilateral Vestibular Schwannoma followed with an MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study.
Primary outcomes (2)
- measure
- Change of Pure Tone Average from baseline
- timeFrame
- 1-year
- description
- Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or above * Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study * Patients willing to take part in the study and give their informed consent Exclusion Criteria: * Previous surgical or radiation therapy for VS (including SRS) * Patients diagnosed with neurofibromatosis type II * Preexisting profound hearing loss, with a pure tone average (PTA) \>90 and word recognition score (WRS) \<10%, upon initial assessment * Previous middle ear surgery of the affected ear * Concurrent treatment with other experimental drugs
References
Publications (0)
Data not yet available