Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- The numbers of participants with preserve hearing [ Time Frame: up to five years after enrollment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]MR investigation including digitalized volumetric of vestibular schwannomas will be performed
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01938677
|Contact: Petter Förander, MD, PhD||+46 8 email@example.com|
|Department of Neurosurgery, Karolinska univeristy hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Theresa Wangerid, MD +46 8 51770000 firstname.lastname@example.org|
|Principal Investigator: Petter Förander, MD, PhD|