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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Karolinska Institutet

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor control [ Time Frame: 1, 2, 5 years after enrollment ]

MR investigation including digitalized volumetric of vestibular schwannomas will be performed


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: September 5, 2013
Date Started: April 2013
Date Completion: December 2020
Last Updated: August 29, 2016
Last Verified: August 2016