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

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Schwannoma
• Intervention / Treatment: Radiation: Initial Gamma knife radiosurgery

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Department of Neurosurgery, Karolinska univeristy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Gamma knife; Patients with VS and preserved hearing, randomized to initial gamma knife radiosurgery will receive this treatment within a few months after enrollment	Radiation: Initial Gamma knife radiosurgery
No Intervention: Initial conservative; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor control	MR investigation including digitalized volumetric of vestibular schwannomas will be performed	1, 2, 5 years after enrollment

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimated): September 10, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Vestibular schwannoma; Gamma knife radiosurgery; Hearing preservation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: 2013/211-31/1