Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Key facts
- Who runs it
- University Hospital, Geneva
- Where
- Geneva, SwitzerlandSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 258 people, planned
- Started
- 24 Jan 2023
- Expected to end
- 15 Nov 2030
- Type of study
- Observational, 2 groups
- Treatments tested
- Stereotactic radiosurgery
- Record updated
- 13 January 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Previous surgical or radiation therapy for VS (including SRS)
- Previous middle ear surgery of the affected ear
- Concurrent treatment with other experimental drugs
- 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
Where in Switzerland
- Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de GenèveGeneva, SwitzerlandContact: Pascal SennTaking people
About the trial
What the trial wants to find out
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.
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Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
The 2 groups in the trial
- Stereotactic radiosurgery group
Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study.
Treatment: Stereotactic radiosurgery
- Wait and scan group
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 13 January 2025