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Vestibular Schwannoma - Radiosurgery or Expectation: V-REX. (V-REX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02249572
Recruitment Status : Unknown
Verified October 2017 by Haukeland University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

The purpose of this study is to compare the outcome of patients with vestibular schwannomas in two groups of randomised to either radiosurgery or expectation.

The optimal treatment for a small vestibular schwannoma is a matter of controversy and there are no class 1 studies investigating this. Even the natural tumor growth rate remains controversial and is reported to be from near 100% of cases showing growth to 40-60% in various reports. The clinical results of various treatment strategies are documented, but comparative studies are very few. Immediate radiosurgery or wait-and scan with subsequent treatment upon growth are two strategies that have both been used in many different centers. There are only two studies comparing these treatment modalities .These studies indicate significant effect of GKRS in reducing tumor growth, with less differences in hearing and complaint outcomes. None of the studies are blinded or randomised, allowing for bias.

The present study aims at comparing the two modalities above. To achieve this, we intend to randomise patients with newly diagnosed VS to either of Wait-and Scan or immediate radiosurgery.

The primary study endpoint is the relative tumor size measured as the ratio between tumor volume at four years compared with volume at inclusion. Secondary endpoints include symptom and sign development measured by clinical examination and by patient's responses to standardised validated questionnaires. In addition, the health economics involved with both strategies will be evaluated and compared, as well as the patient's working status.

Patients will be asked to participate if their VS is diagnosed within the last six months, their age is between 18 and 70, and pending there are no exclusion criteria (see below). A power analysis indicates that about 50 patients per group is sufficient.

In case of failure to recruit patients, we will change the design to a study based on patient's own choice of treatment.

The study will be announced according to international guidelines. A steering committee will monitor the study and an intermediate analysis will be performed when the study group has been followed for two years. If the effect aim is already observed, the study should nonetheless continue, as it is too early to evaluate the results after such a short time course.

It will also be discussed to do a follow-up of all patients ten years after inclusion.


Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Radiation: gamma knife radiosurgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomization of 100 individuals to radiosurgery or expectative treatment of vestibular schwannoma.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Study investigator masked to whether patient has had radiosurgery og no active treatment. Scars due to radiosurgery frame hidden With surgical cap at all study consultations in all pts. Radiologist measuring tumor size masked as to treatment
Primary Purpose: Treatment
Official Title: Vestibular Schwannoma - Radiosurgery or Expectation
Study Start Date : October 2014
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: gamma knife radiosurgery
Single fraction gamma knife radiosurgery given at 12 Gy to tumor periphery for vestibular schwannoma
Radiation: gamma knife radiosurgery
Leksell Perfection model gamma knife.

No Intervention: Expectation
No active treatment given for vestibular schwannoma



Primary Outcome Measures :
  1. Relative Tumor volume [ Time Frame: 4 years ]
    Growth measured as volume ratio V4years/Vbaseline and 1/volume doubling time


Secondary Outcome Measures :
  1. Hearing acuity [ Time Frame: 4 years ]
    Hearing acuity according to Gardner Robertson scale at four years

  2. Conversion to other treatment during study period [ Time Frame: 4 years ]
    If patient is in need of other treatment for tumor (radiosurgery, microsurgery, other) within the time frame of the study

  3. Subjective complaints [ Time Frame: 4 years ]
    Penn Vestibular Schwannoma QOL Scale (PANQOL) EQ-50 Scale


Other Outcome Measures:
  1. Neurovestibular testing [ Time Frame: 4 years ]
    Outcomes of caloric test and Balance Platform test (Equitest, SOT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vestibular schwannoma diagnosed by MRI of less than 6 months.
  • Diameter 4-20mm. Willing to participate. Age 18 -70 years.

Exclusion Criteria:

  • Dementia
  • Active malignant disease
  • Type II neurofibromatosis in patient or first grade relative.
  • Other severe co-morbidity
  • Type 2 neurofibromatosis in patient or first-grade relative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249572


Locations
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Norway
Haukeland Unviersity Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Morten Lund-Johansen, MD PhD Haukeland University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02249572    
Other Study ID Numbers: 2014/314
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: October 2017
Keywords provided by Haukeland University Hospital:
Vestibular schwannoma
Radiosurgery
Neurosurgery
Randomized
Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
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