Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

NCT05641441 | Recruiting

• 1 other identifier: 2022-01257
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Vestibular Schwannoma; Ototoxicity

Keywords

Radiosurgery; Ototoxicity; Vestibular Schwannoma; Hearing loss; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

  1-year

• 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

  1-year

Secondary Outcomes (13)

• Change of Pure Tone Average from baseline

  3 and 5-year

• Change of High-frequency Pure Tone Average from baseline

  1, 3 and 5-year

• Change of Word recognition score from baseline

  3 and 5-year

• Change of video-oculography from the baseline

  1, 3 and 5-year

• Change of caloric ipsilateral testing (degree of asymmetry) from baseline

  1, 3 and 5-year

Study Arms (2)

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.

Radiation: 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.

Interventions

Stereotactic radiosurgery RADIATION

Stereotactic radiosurgery

Stereotactic radiosurgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Neuroma, Acoustic; Ototoxicity; Hearing Loss

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pascal Senn

CONTACT

0223728244; pascal.senn@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Service of Otorhinolaryngology-Head and Neck Surgery, Department of clinical neurosciences, Geneva University Hospitals

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 7, 2022
• Study Start: January 24, 2023
• Primary Completion (Estimated): November 15, 2030
• Study Completion (Estimated): November 15, 2030
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CH (1)