Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study will be conducted at the Geneva University Hospitals (tertiary care facility) in Switzerland. For the retrospective part of our research project, the investigators aim to analyze non-genetic health-related personal data in a coded form from approximately 150 patients treated between 2014 and 2021. Regarding the prospective study part, patient recruitment will be done through the multidisciplinary skull base tumor board, where cases are discussed in detail, treatment decisions are made consensually based on the contribution of different specialists and in agreement with the current international recommendations. Patients eligible for study inclusion will be contacted to obtain informed consent. The investigators aim to include 108 participants.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Stereotactic radiosurgery
RadiationStereotactic radiosurgery
Treatment groups
258 Participants
are divided into 2 treatment groupsGroup A: Stereotactic radiosurgery group1 intervention
Group B: Wait and scan group0 interventions
Trial outcomes
Primary outcomes
1
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Time frame
1-year2
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Time frame
1-yearSecondary outcomes
1
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Time frame
3 and 5-year2
Change of High-frequency Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 3000 Hz, 4000 Hz and 6000 Hz.
Time frame
1, 3 and 5-year3
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Time frame
3 and 5-year4
Change of video-oculography from the baseline
Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit
Time frame
1, 3 and 5-yearSponsors and contacts
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Source ClinicalTrials.gov