Table 1

WHO registration data set

Title	Protocol for a randomised, observer-blinded study to compare the impact of up-front radiosurgery versus expectation in vestibular schwannoma (The V-REX Study)
Primary registry and trial identifying number	ClinicalTrials.gov NCT02249572
Secondary identifying numbers	The Western Norway Regional Health Authority: 912 281
	Regional Ethical Committee (REC West): 23 503
	Haukeland University Hospital record: 2014/314
Sources of monetary or material support	Costs associated with study are financed by research donations from The Western Norway Regional Health Authority (Helse Vest HF), and The Norwegian National Unit for Vestibular Schwannomas.
Sources of monetary or material support	Patients are recruited from outpatient consultations, and most of the routine patient handling is financed over the budgets of The Department of Neurosurgery, Haukeland University Hospital. Data are collected according to clinical consultations that take place routinely at follow-up, with the additional assessment of a blinded observer.
Primary sponsor	The Western Norway Regional Health Authority
Primary sponsor	Grant number: 912 281
Secondary sponsor(s)	The Norwegian National Unit for Vestibular Schwannomas
Study principal investigator	Morten Lund-Johansen, MD PhD
	Haukeland University Hospital
	Jonas Lies Vei 65, 5021 Bergen
	+47 55975666
	morten.lund-johansen@helse-bergen.no
Corresponding author	Dhanushan Dhayalan, MD
	Haukeland University Hospital
	Jonas Lies vei 65, 5021 Bergen
	+47 98648969
	dhanushan.dhayalan@helse-bergen.no
Protocol authors	Dhanushan Dhayalan, MD PhD
	Øystein Vesterli, Tveiten, MD PhD
	Frederik Kragerud Goplen, MD PhD
	Anette Storstein, MD PhD
	Monica Finnkirk, RN
	Eli Renate Grüner, MD PhD
	Morten Lund-Johansen, MD PhD
Other study investigators	Terje Sundstrøm, MD PhD
	Erling Myrseth, MD PhD
	Linda Fauske, RN
	Øystein Fluge, MD PhD
	Greg Jablonski, MD PhD
	Erling Andersen, MSc PhD
	Jeanette Hess-Erga, MD PhD
	Roy Miodini Nilsen, MSc PhD
	Karl Ove Hufthammer, MSc PhD
Brief title	Vestibular Schwannoma, Radiosurgery or Expectation?
Acronym	V-REX
Countries of recruitment	Norway
Condition(s) or focus of study	Vestibular Schwannoma
Interventions
Radiosurgery group	Intervention type: Procedure/Radiosurgery
	Intervention name: Gamma Knife Radiosurgery
	Intervention description: Patients receiving radiosurgery undergo treatment within 2 months following randomisation. Radiosurgery is given according to a standard dose plan of 12 Gy to the tumour periphery. The maximal dose, number of shots and the brainstem and cochlea doses are reported.
	Intervention type: diagnostic test
	Intervention name: MRI
	Intervention description: gadolinium-enhanced T1-weighted MRI.
	Intervention type: diagnostic test
	Intervention name: audiometry, stabilometry and nystagmometry
Observation Group	Intervention type: other
	Intervention name: observation
	Intervention description: patients undergoing observational treatment are assigned to annual clinical and radiological follow-up.
	Intervention type: diagnostic test
	Intervention name: MRI
	Intervention description: gadolinium-enhanced T1-weighted MRI.
	Intervention type: diagnostic test
	Intervention name: audiometry, stabilometry and nystagmometry
Key eligibility criteria	Age eligibility: 18–70 years
	Sex eligibility: both
	Accepts healthy volunteers: no
	Inclusion criteria:
	Newly diagnosed vestibular schwannoma by MRI of less than 6 months with cerebellopontine angle (CPA) diameter less than 20 mm
	Exclusion criteria:
	1.Type II neurofibromatosis in patient or first grade relative.
	2.Severe comorbidity
	3.Unwilling/not fit for participation for other reasons (ex. alcohol abuse, personality disorder, language problems)
Study design	Study type: interventional trial
	Allocation: randomised
	Intervention model: parallel group
	Primary purpose: treatment
	Phase: N/A
Masking	Investigators, outcome assessors
Date of enrollment	28 October 2014
Target sample size	100
Recruitment status	Active, not recruiting
Primary outcomes	Outcome: growth measured as volume ratio V_4years/V_baseline and volume-doubling time (VDT), evaluated by T1 contrast MRI volumetry.
Primary outcomes	Timeframe: 4 years
Secondary outcomes	Outcome: subjective complaints assessed by observer-blinded clinical follow-ups and questionnaires
	Timeframe: 4 years
	Outcome: Penn Acoustiv Neuroma Quality-of-Life (PANQOL) scale
	Timeframe: 4 years
	Outcome: EuroQol 5 Dimension 3 Level Response (EQ-5D-3L)
	Timeframe: 4 years
	Outcome: Hearing acuity according to Gardner Robertson scale (safety endpoint)
	Timeframe: 4 years
	Outcome: posturography and caloric function
	Timeframe: 4 years
	Outcome: Conversion to other treatment during study period
	Timeframe: 4 years
	Outcome: adverse effects
	Timeframe: 4 years