BRITER study
Research type
Research Study
Full title
Brain Imaging to predict Toxicity in Elderly patients after Radiotherapy
IRAS ID
216343
Contact name
Cressida Lorimer
Contact email
Sponsor organisation
Brighton and Sussex NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Our aim with the BRITER study is to produce a way of predicting who might be more or less likely to suffer side effects from radiotherapy prior to starting treatment for a glioblastoma (GBM), a type of brain tumour. This will enable doctors and patients to make more individual, tailored treatment plans.
GBM is the commonest primary malignant brain tumour. The chances of developing a GBM peak in your 70s and 80s. Outcomes in older patients are poor. Part of the reason is the lack of good clinical trials for this age group. Treatment options include chemotherapy, radiotherapy or best supportive care. The focus should be on maintaining a good quality of life for as long as possible.
Research has shown that there is a test oncologists can perform on tumours which suggests whether that tumour is more or less sensitive to chemotherapy. This test is used to guide whether chemotherapy is offered. There is no such test to guide radiotherapy treatment.
Radiotherapy to the brain is an effective treatment, however it can produce side effects. The degree of side effects different patients experience can vary widely. Some of this due to the amount of radiotherapy given and how it’s given but there is a lot that we don’t understand. It has been thought that if the patient’s underlying normal brain (i.e. not the part affected by the tumour) is fragile due to an underlying mild dementia or problems associated with high blood pressure or cholesterol then this might make them more vulnerable.
MRI scans can be used to assess whether there are changes in the normal brain. The BRITER study aims to use MRI scans to see whether we can predict those patients who might be more at risk of side effects from radiotherapy. The trial is aimed at patients aged > 65 who have been newly diagnosed with a GBM and are going to receive radiotherapy. Patients who agree to take part in the trial will have had an MRI scan as part of their normal diagnosis. They will undertake some questionnaires before starting their radiotherapy which will aim to assess their quality of life and their mental processes of perception, memory, judgment, and reasoning (called cognitive function).
They will repeat these questionnaires 4 and 8 weeks after their treatment when they come for their follow up appointments. We will compare them to measurements made on the pre-treatment MRI scan. Occasionally the MRI scan the patients had as part of their diagnosis will not have enough information on it and some patients may need to have an extra scan before their radiotherapy starts.
Participation in the study does not change the treatment the patient receives.
We hope that the BRITER study will enable us to predict the degree of side effects a patient is likely to experience before embarking on radiotherapy treatment. This will enable more informative, individualised discussions surrounding the best treatment path for older patients with a GBM.
Summary of Results
The BRITER study opened to recruitment of patients in August 2019 and closed in November of 2021. The lead researcher was Dr Cressida Lorimer at University Hospitals Sussex NHS Trust. This Trust also acted as the Sponsor for the study. The study was open across 13 oncology centres in the UK; Sussex Cancer Centre, Kent Oncology Centre, The Royal Marsden NHS Trust, Imperial College Healthcare NHS Trust, Mount Vernon Hospital, Norfolk and Norwich University Hospitals Foundation Trust, Cambridge University Hospitals NHS Trust, Hull University Teaching Hospitals NHS Trust, University Hospitals Birmingham, The Christie NHS Foundation Trust, Nottingham University Hospitals NHS Trust, The Beatson West of Scotland Cancer Centre and Edinburgh Cancer Centre. It was funded by contributions from The Sussex Cancer Fund and BrainsTrust and there were no competing interests declared.
In the design of the study, patient and public involvement was sought through the Sponsor, The Brain Tumour Charity and BrainsTrust patient and carer focus groups. Their feedback was instrumental in restructuring the protocol and PIS to make the design of the study clearer to understand. They unanimously agreed that the objectives of the study were worth pursuing and that it was a valid study question.
The BRITER study aimed to assess whether you can use changes seen on brain MRI scans to predict who may develop a worsening of quality of life after radiotherapy treatment for a Glioblastoma. Glioblastomas are an aggressive and almost universally fatal form of primary brain tumour. Prognosis is limited and in the older age group is around 6 months. Palliative oncological treatment can be given in the form of radiotherapy, with or without chemotherapy. The aim of this treatment is to extend patient’s lives while maintaining quality of life. Some patients seem to experience worse short term side effects from radiotherapy than others. These can include fatigue, headaches, poor memory and less ability to complete everyday tasks. The BRITER study aimed to assess whether you can use patients’ pre-treatment MRI scans to see if radiological markers can predict those patients who may experience worse acute side effects, as measured by an impact on their quality of life. This could then be used to help patients decide on whether they would like to have radiotherapy as part of their treatment.
Eligible patients were those aged 65 or over who had been newly diagnosed with a Glioblastoma and were being planned for radiotherapy treatment to the brain, with or without chemotherapy. Patients underwent an extra MRI scan of their brain prior to treatment and then filled in questionnaires designed to assess their quality of life. They also had a nurse-led assessment including memory testing before starting treatment, 3-5 weeks after finishing radiotherapy and 7-9 weeks after finishing radiotherapy.
The BRITER study originally aimed to recruit 100 patients however due to the COVID pandemic the number of patients who completed their questionnaires and assessments was less than predicted. We therefore submitted an amendment and increased the recruitment total to 127. This was reached in the winter of 2021. There were no adverse effects reported during the study.
The results of the BRITER study are not yet available. Follow up data was completed on the 31.12.21 and ongoing data analysis is being performed. We are predicting this data should be available by Spring of 2023.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/0997
Date of REC Opinion
15 Jun 2018
REC opinion
Favourable Opinion