Trial record 5 of 56 for:    "Schwannoma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Petter Forander, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01938677
First received: September 5, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention
Vestibular Schwannoma
Radiation: Initial Gamma knife radiosurgery

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients newly (<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
  2. Vestibular schwannoma with or without evidence of growth.
  3. Patients between 18 and 80 years of age.
  4. Karnofsky performance score >70
  5. 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.

    -

Exclusion Criteria:

  • 1. Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.

    2. 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.

    3. 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.

    4. Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.

    5. Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.

    6. Claustrophobia, making MR follow up impossible without sedation. 7. Alcohol- or narcotic abuses that effect compliance to the follow up. 8. Uncontrolled neoplastic disease.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938677

Contacts
Contact: Petter Förander, MD, PhD +46 8 51770377 petter.forander@arolinska.se

Locations
Sweden
Department of Neurosurgery, Karolinska univeristy hospital Recruiting
Stockholm, Sweden, 17176
Contact: Theresa Wangerid, MD    +46 8 51770000    theresa.wangerid@gmail.com   
Principal Investigator: Petter Förander, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Petter Forander, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01938677     History of Changes
Other Study ID Numbers: 2013/211-31/1
Study First Received: September 5, 2013
Last Updated: March 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Vestibular schwannoma
Gamma knife radiosurgery
Hearing preservation

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neuroma
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neoplasms by Site
Cranial Nerve Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on July 24, 2014