Clinical Trial: Vestibular Schwannoma - Radiosurgery or Expectation: V-REX.

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

Official Title: Vestibular Schwannoma - Radiosurgery or Expectation

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 cr

Detailed Summary:

Study design and purpose:

Design: Randomised study blinded to observer on primary endpoint (tumor volume). Intention-to-treat, ie patients who cross over from conservative to GKRS group during the study period are assigned to their original group. Patients who refrain from radiosurgery despite randomisation are assigned to radiosurgery group.

Purpose: compare the treatment of small and medium-sized VS treated with a standardised dose of 12 Gy to the tumor periphery with expectative treatment.

Primary endpoint:

Growth measured as volume ratio V4years/Vbaseline and 1/volume doubling time, evaluated by T1 contrast MRI volumetry at one, two, three and four years.

Secondary endpoints:

Hearing acuity according to Gardner Robertson scale at four years (safety endpoint).

Conversion to other treatment during study period Adverse effects

Subjective complaints assessed by questionnaires:

Penn Vestibular Schwannoma QOL Scale EQ-50 Scale

Investigations:

Prior to inclusion: MRI less than 6 months showing VS.

After inclusion and at 1,2 3,4 years, all at study site:

MRI of inner ear (acoustic neuroma protocol) Balance platform Nystagmometry Audiometry

Effect registration:

Main variable:

Growth measured as volume ratio V4years/Vbaseline and 1/volume doubling time