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

NCT01938677 | Completed

• 1 other identifier: 2013/211-31/1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Vestibular schwannoma; Gamma knife radiosurgery; Hearing preservation

Outcome Measures

Primary Outcomes (1)

• 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.

  up to five years after enrollment

Secondary Outcomes (1)

• Tumor control

  1, 2, 5 years after enrollment

Study Arms (2)

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

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.

Interventions

Initial Gamma knife radiosurgery RADIATION

Initial Gamma knife

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.
• \. 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.
• \. 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.
• \. Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.
• \. Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.
• \. Claustrophobia, making MR follow up impossible without sedation. 7. Alcohol- or narcotic abuses that effect compliance to the follow up. 8. Uncontrolled neoplastic disease.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Neurosurgery, Karolinska univeristy hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

SE (1)