Clinical trial NCT01938677: Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
Official title: Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Schwannoma
Keywords: Vestibular schwannoma
Gamma knife radiosurgery
Hearing preservation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. Recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients.

The main objective of this study is to evaluate if GKRS can inhibit progression of hearing loss in patients with VS. Patients with preserved hearing will be offered to participate in the study and randomized ether to GKRS or initial conservative treatment for their vestibular schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and audiometry and evaluated after one, three and five years after treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients newly (\<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
2. Vestibular schwannoma with or without evidence of growth.
3. Patients between 18 and 80 years of age.
4. Karnofsky performance score \>70
5. 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.

Primary outcomes:
measure: The numbers of participants with preserve hearing
timeFrame: up to five years after enrollment
Secondary outcomes:
measure: Tumor control
timeFrame: 1, 2, 5 years after enrollment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Neurosurgery, Karolinska univeristy hospital
Study officials:
References: