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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

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:

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.

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

NCT ID

NCT01938677

First Posted

September 5, 2013

Last Updated

May 12, 2023

Sponsor

Karolinska Institutet

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

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

Intervention Type

Radiation

Intervention Name(s)

Initial Gamma knife radiosurgery

Primary Outcome Measure Information:

Title

The numbers of participants with preserve hearing

Description

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

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

Learn more about this trial

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

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