Clinical

We currently are leading three international clinical research studies involving patients with meningioma:

  • ROAM
  • PROMM-UK
  • FACT-MNG

ROAM – Radiation versus Observation following surgical resection of Atypical Meningioma

ROAM is a multi-centre, randomised controlled trial to compare radiotherapy versus active monitoring in patients who have undergone gross total surgical resection (Simpson 1-3) of atypical (grade II) meningioma.

The primary objective of the ROAM trial is to determine whether early adjuvant fractionated external beam radiotherapy reduces the risk of tumour recurrence compared to active monitoring in newly diagnosed atypical meningioma. Meningiomas comprise 25-33% of adult primary brain tumours. The annual UK incidence of atypical meningioma is 0.2-0.5 / 100,000 / year and ~150 undergo surgical resection each year. Since the publication of the 2000 WHO classification, the reported incidence of atypical meningioma has risen to 20-35%, nevertheless they remain very rare.

Benign (grade I) meningioma have a low risk of recurrence (~10% at 5 years) following surgical resection and are managed by active monitoring with MRI scans. Adjuvant radiotherapy is indicated for anaplastic (grade III) meningioma to prolong time to recurrence however 5-year progression free survival is only ~10%. The role of radiotherapy in atypical (grade II) meningioma after gross total resection has not been defined and there is no agreement on the current standard of care for patients with atypical meningioma.

Recruitment to this trial is ongoing. For further information please visit http://www.roam-trial.org.uk/.

PROMM-UK – Patient-Reported Outcome Measure for Meningiomas in the UK

PROMM-UK is an international collaboration to create a new way of evaluating quality of life in patients diagnosed with a meningioma.  Meningiomas can cause various symptoms, such as loss of strength, seizures, headaches and memory problems. These deficits can have a negative impact on patient’s quality of life. Currently, it is unclear what the exact impact is of a meningioma and its treatment on patient’s quality of life. Although several questionnaires exist to measure quality of life, previous research showed that these questionnaires were found to be inadequate for meningioma patients. Many questions in these questionnaires were not relevant for meningioma patients and questions relevant for meningioma patients were missing. Therefore, we think it is necessary to develop a new quality of life questionnaire specifically for meningioma patients. Such a questionnaire could be used in clinical practice to assist the clinician in making treatment decisions, as it provides information on the functioning and quality of life of patients. In addition, it may improve physician-patient communication, because such a questionnaire helps to discuss problems and issues relevant for the patient.

Six hospitals in the UK (The Walton Centre in Liverpool, Addenbrooke’s Hospital in Cambridge, John Radcliffe Hospital in Oxford, Queen’s Hospital in Romford, Salford Royal Hospital in Manchester, and St. Bartholomew’s and the Royal London) will be participating in this international study led from the Netherlands.

Recruitment to this study is expected to begin in early 2019. For further information please contact Daniel Fountain at daniel.fountain@nhs.net.

FACT-MNG

Very little is known about pre and post-treatment quality of life (QOL) after therapy for meningiomas, a factor of increasing interest to both clinicians and patients. Our colleagues and collaborators from the University of California, San Francisco (UCSF) have developed a bespoke QOL measure, the FACT-MNG scale, to measure QOL in patients with meningioma, before and after treatment. This scale has elements of validated QOL scales (FACT-BR and SF-36) along with site-specific questions for 11 different locations of meningiomas. It can be easily completed by the patient at specific follow-up time points using an online platform easily accessible from any computer or mobile device.

Additional research is needed to provide a more comprehensive understanding of post treatment quality of life, and to directly correlate quality of life with surgical outcomes. Furthermore, it would be beneficial to identify predictive factors (patient factors, tumour factors, treatment factors) that impact quality of life. This information is critical for neurosurgeons and patients to make informed decisions on whether to proceed with intervention and if so, with what intervention.

This study will be a UK-wide online platform based prospective multicentre study to assess pre- and post-treatment quality of life in patients with meningioma using the FACT-MNG scale. We will aim to recruit 500 patients at first presentation of meningioma to a neuro-oncology clinic, whether undergoing surveillance or any form of active treatment. At the end of the study, we will have the opportunity to analyse both the UK data and the combined data along with the parallel study running at UCSF to develop a more detailed understanding of the QOL changes over time in patients who undergo both surveillance and active treatment for meningioma.

Recruitment to this study is expected to begin in early 2019. For further information please contact Aswin Chari at aswinchari@gmail.com and Christopher Millward at christopherpaulmillward@gmail.com.