Vestibular SchwannomaNCT01938677
Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
A study testing Initial Gamma knife radiosurgery in people with Vestibular Schwannoma, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Initial Gamma knife radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Neurosurgery, Karolinska univeristy hospital
Stockholm, 17176
About this 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.
- Conditions
- Vestibular Schwannoma
- Being tested
- Initial Gamma knife radiosurgery
- Keywords
- Vestibular schwannoma, Gamma knife radiosurgery, Hearing preservation
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Gamma knife radiosurgeryRadiation
| Study group | Role | What they receive |
|---|---|---|
| Initial Gamma knife | Experimental | Patients with VS and preserved hearing, randomized to initial gamma knife radiosurgery will receive this treatment within a few months after enrollment Receives: Radiation: Initial Gamma knife radiosurgery |
| Initial conservative | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to five years after enrollment
Secondary outcomes (1)
Tumor control
MR investigation including digitalized volumetric of vestibular schwannomas will be performed
Measured: 1, 2, 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petter Forander, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938677
- Sponsor's protocol ID
- 2013/211-31/1
- Status last verified
- Apr 2024
- First submitted
- 5 Sep 2013
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartek J, Benmakhlouf H, Frostell A, Wangerid T, Jakola AS, Al-Saffar Y, Samadi A, Gubanski M, Lippitz B, Forshell Hederstierna C, Forander P. Hearing Preservation After Upfront Gamma Knife Radiosurgery Versus Initial Conservative Management in Patients With Newly Diagnosed Vestibular Schwannoma: Results From a Prospective Randomized Study. Neurosurgery. 2026 Apr 2. doi: 10.1227/neu.0000000000004016. Online ahead of print.
PubMed 41925729
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01938677
- Acronym / sponsor ID
- 2013/211-31/1
- Conditions
- Vestibular Schwannoma
- Keywords
- Vestibular schwannoma, Gamma knife radiosurgery, Hearing preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Gamma knife | Experimental | Radiation: Initial Gamma knife radiosurgeryPatients with VS and preserved hearing, randomized to initial gamma knife radiosurgery will receive this treatment within a few months after enrollment |
| Initial conservative | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial Gamma knife radiosurgery | Radiation | Initial Gamma knife |
Primary outcome
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.
1 secondary outcome
Tumor control
Time frame: 1, 2, 5 years after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 41925729Bartek J, Benmakhlouf H, Frostell A, Wangerid T, Jakola AS, Al-Saffar Y, Samadi A, Gubanski M, Lippitz B, Forshell Hederstierna C, Forander P. Hearing Preservation After Upfront Gamma Knife Radiosurgery Versus Initial Conservative Management in Patients With Newly Diagnosed Vestibular Schwannoma: Results From a Prospective Randomized Study. Neurosurgery. 2026 Apr 2. doi: 10.1227/neu.0000000000004016. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Gamma knife radiosurgery in people with Vestibular Schwannoma, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numbers of participants with preserve hearing (time frame: up to five years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.