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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Tumor control [ Time Frame: 1, 2, 5 years after enrollment ]
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