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

Primary Purpose

Vestibular Schwannoma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Initial Gamma knife radiosurgery
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Schwannoma focused on measuring Vestibular schwannoma, Gamma knife radiosurgery, Hearing preservation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurosurgery, Karolinska univeristy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Initial Gamma knife

Initial conservative

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tumor control
MR investigation including digitalized volumetric of vestibular schwannomas will be performed

Full Information

First Posted
September 5, 2013
Last Updated
May 12, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01938677
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Vestibular schwannoma, Gamma knife radiosurgery, Hearing preservation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial Gamma knife
Arm Type
Experimental
Arm Description
Patients with VS and preserved hearing, randomized to initial gamma knife radiosurgery will receive this treatment within a few months after enrollment
Arm Title
Initial conservative
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Initial Gamma knife radiosurgery
Primary Outcome Measure Information:
Title
The numbers of participants with preserve hearing
Description
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.
Time Frame
up to five years after enrollment
Secondary Outcome Measure Information:
Title
Tumor control
Description
MR investigation including digitalized volumetric of vestibular schwannomas will be performed
Time Frame
1, 2, 5 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. - 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.
Facility Information:
Facility Name
Department of Neurosurgery, Karolinska univeristy hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

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

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