Vestibular Schwannoma - Radiosurgery or Expectation: V-REX.

NCT02249572 | Completed DMC

• 1 other identifier: 2014/314
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Vestibular schwannoma; Radiosurgery; Neurosurgery; Randomized

Outcome Measures

Primary Outcomes (1)

• Relative Tumor volume

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

  4 years

Secondary Outcomes (3)

• Hearing acuity

  4 years

• Conversion to other treatment during study period

  4 years

• Subjective complaints

  4 years

Other Outcomes (1)

• Neurovestibular testing

  4 years

Study Arms (2)

gamma knife radiosurgery

EXPERIMENTAL

Single fraction gamma knife radiosurgery given at 12 Gy to tumor periphery for vestibular schwannoma

Radiation: gamma knife radiosurgery

Expectation

NO INTERVENTION

No active treatment given for vestibular schwannoma

Interventions

gamma knife radiosurgery RADIATION

Leksell Perfection model gamma knife.

gamma knife radiosurgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland Unviersity Hospital

Bergen, 5021, Norway

Location

Related Publications (2)

• Dhayalan D, Tveiten OV, Finnkirk M, Storstein A, Hufthammer KO, Goplen FK, Lund-Johansen M; V-REX Trial investigators. Upfront Radiosurgery vs a Wait-and-Scan Approach for Small- or Medium-Sized Vestibular Schwannoma: The V-REX Randomized Clinical Trial. JAMA. 2023 Aug 1;330(5):421-431. doi: 10.1001/jama.2023.12222.

  PMID: 37526718 RESULT

• Dhayalan D, Tveiten OV, Goplen FK, Finnkirk MK, Storstein AM, Gruner ER, Lund-Johansen M. Comparing the impact of upfront radiosurgery versus expectation in vestibular schwannoma (the V-REX study): protocol for a randomised, observer-blinded, 4-year, parallel-group, single-centre, superiority study. BMJ Open. 2021 Mar 17;11(3):e039396. doi: 10.1136/bmjopen-2020-039396.

  PMID: 33737417 DERIVED

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Radiosurgery

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Morten Lund-Johansen, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization of 100 individuals to radiosurgery or expectative treatment of vestibular schwannoma.

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2021
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

NO (1)