Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
Vestibular Schwannoma
About this trial
This is an interventional treatment trial for Vestibular Schwannoma focused on measuring Vestibular schwannoma, Gamma knife radiosurgery, Hearing preservation
Eligibility Criteria
Inclusion Criteria:
- Patients newly (<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
- Vestibular schwannoma with or without evidence of growth.
- Patients between 18 and 80 years of age.
- Karnofsky performance score >70
Patients with vestibular schwannoma and preserved hearing according to Gardner Robertson class 1-2, and speech discrimination (SD) scores between 50-100% will participate in the hearing preservation part of the study.
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Exclusion Criteria:
1. Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.
2. Patients who had other treatments prior to the GKRS (usually microsurgery (MS), GKRS or external beam radiation) for their tumour will also be excluded for the same reason.
3. Patients who are not citizens in the country where they will be followed will be excluded, to reassure the same follow up within the study population.
4. Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.
5. Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.
6. Claustrophobia, making MR follow up impossible without sedation. 7. Alcohol- or narcotic abuses that effect compliance to the follow up. 8. Uncontrolled neoplastic disease.
Sites / Locations
- Department of Neurosurgery, Karolinska univeristy hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Initial Gamma knife
Initial conservative
Patients with VS and preserved hearing, randomized to initial gamma knife radiosurgery will receive this treatment within a few months after enrollment
Patients with VS and preserved hearing, randomized to initial conservative treatment will initially be followed with repeated MRI and audiometry. If MRI show progression of VS requiring intervention, patients will receive treatment but still belong to the initial treatment arm, according to intention to treat.