Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

Vestibular Schwannoma Clinical Trial

Official title:

Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938677
• Other study ID #: 2013/211-31/1
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2022

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Radiation:
• Initial Gamma knife radiosurgery

Locations

Country	Name	City	State
Sweden	Department of Neurosurgery, Karolinska univeristy hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The numbers of participants with preserve hearing	Baseline audiometric investigation will be performed at time of enrollment. Patients will be followed with audiometric investigations after 1, 3 and 5 years after gamma knife or conservative treatment.Primary endpoint will be numbers of patients with preserve hearing for each treatment arm.	up to five years after enrollment
Secondary	Tumor control	MR investigation including digitalized volumetric of vestibular schwannomas will be performed	1, 2, 5 years after enrollment