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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01938677|
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : August 30, 2016
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|
|Vestibular Schwannoma||Radiation: Initial Gamma knife radiosurgery|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Tumor control [ Time Frame: 1, 2, 5 years after enrollment ]MR investigation including digitalized volumetric of vestibular schwannomas will be performed
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938677
|Contact: Petter Förander, MD, PhD||+46 8 firstname.lastname@example.org|
|Department of Neurosurgery, Karolinska univeristy hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Theresa Wangerid, MD +46 8 51770000 email@example.com|
|Principal Investigator: Petter Förander, MD, PhD|