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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01938677
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : August 29, 2019
Information provided by (Responsible Party):
Petter Forander, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Radiation: Initial Gamma knife radiosurgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
Study Start Date : April 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.

Primary Outcome Measures :
  1. The numbers of participants with preserve hearing [ Time Frame: up to five years after enrollment ]
    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.

Secondary Outcome Measures :
  1. Tumor control [ Time Frame: 1, 2, 5 years after enrollment ]
    MR investigation including digitalized volumetric of vestibular schwannomas will be performed

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01938677

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Department of Neurosurgery, Karolinska univeristy hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
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Responsible Party: Petter Forander, MD, PhD, Karolinska Institutet Identifier: NCT01938677    
Other Study ID Numbers: 2013/211-31/1
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Keywords provided by Petter Forander, Karolinska Institutet:
Vestibular schwannoma
Gamma knife radiosurgery
Hearing preservation
Additional relevant MeSH terms:
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Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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