Brain Imaging to Predict Toxicity in Elderly Patients After Radiotherapy

NCT05671016 | Completed

• 1 other identifier: BRITER
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' 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. GBM is the commonest primary malignant brain tumour. 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. 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. It has been thought that if the patient's underlying normal brain is fragile due to an underlying mild dementia or problems associated with high blood pressure or cholesterol then this might make them more vulnerable to radiotherapy. 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 the investigators 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. Participants 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). Participants may also need an extra MRI scan. Participants will repeat these questionnaires 4 and 8 weeks after treatment when they come for their follow up appointments. The investigators will compare them to measurements made on the pre-treatment MRI scan. Participation in the study does not change the treatment the patient receives. The investigators hope that the BRITER study will enable them 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.

Conditions

Glioblastoma Multiforme, Adult; Radiation Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life at 8 weeks post treatment.

  Participants will complete validated quality of life questionnaires at baseline and at 8 weeks after treatment. The main outcome measure is the EORTC QLQ-C30 questionnaire. This will be scored and then assessed for differences between baseline and the 8 week score to assess for a clinically significant (10 point change) in score. The scores shall be calculated using the EORTC scoring manual which involves reverse scoring some domains. A higher overall score indicates a better quality of life.

  8 weeks (+/- 1 week) after completing radiotherapy to the brain

Secondary Outcomes (4)

• Overall survival

  This will be calculated from the date of diagnosis of a Glioblastoma to the date of death or the date the study is censored (set at 31/12/2021, 16 months after the final patient is recruited) whichever is first

• Change in score on MOCA cognitive screening questionnaire

  at 8 weeks (+/- 1 week) after treatment complete

• Change in score in EORTC BN20 questionnaire

  Between baseline and 8 weeks

• Change in score in EORTC ELD-14 questionnaire

  Between baseline and 8 weeks

Other Outcomes (6)

• Total brain volume (as a ratio of total intracranial volume to CSF) (mm3)

  Baseline

• Contralateral medial temporal lobe volume (mm3)

  Baseline

• Volume of T1 white matter hyperintensities in contralateral hemisphere (mm3)

  Baseline

Study Arms (1)

Patient aged 65 or older receiving radiotherapy treatment for a newly diagnosed GBM

Patients aged 65 or older who have been newly diagnosed with a Glioblastoma (either through histological confirmation or confirmed by a consultant radiologist in a multidisciplinary team meeting setting) who are planned to be treated with radiotherapy. There is only 1 arm in this study, there is no randomisation. All participants will undertake questionnaires (as described in detail elsewhere in the form) and if the required MRI sequences are not available on their diagnostic imaging then they will undertake a trail specific MRI scan.

Procedure: MRI scans and questionnaires

Interventions

MRI scans and questionnaires PROCEDURE

Extra baseline MRI scan performed and questionnaires (EORTC validated questionnaires involving EORTC QLQ C-30, EORTC BN20 and EORTC ELD14) to assess quality of life at baseline, 4 weeks and 8 weeks after treatment

Patient aged 65 or older receiving radiotherapy treatment for a newly diagnosed GBM

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 or over with newly diagnosed Glioblastoma Multiforme planning to receive radiotherapy to the brain

You may qualify if:

• Patients aged \> 65 years with a new diagnosis of GBM. Diagnosis made via histological confirmation following biopsy or debulking surgery or radiologically during a Multidisciplinary meeting (MDM) confirmed by a consultant neuro radiologist. This lower age limit is due to previous clinical trials which have established gold standard treatment regimes for patients under the age of 65. Patients aged 65 or over have less clinical trial data available to them and treatment decisions are more nuanced with a greater emphasis on quality of life given the poorer prognosis of older patients.
• Patients undergoing radiotherapy treatment to the brain for treatment of their GBM
• Patients able to undergo an MRI scan
• Patients undergoing treatment at one of the study centres
• Patient have capacity to participate in the study
• Patients with physical impairments that prevent them filling in their questionnaires involved in the study may still participate if they are able to communicate their answers though a third party

You may not qualify if:

• Patients not fit for radiotherapy treatment or having single agent chemotherapy with no radiotherapy
• Patients lacking capacity
• Patients who do not have sufficient grasp of the English language to be able to complete the questionnaires
• Patients unable to communicate their responses to the questionnaires
• Patients who are concurrently enrolled in a Clinical Trial of an Investigational Medicinal Product (CTIMP)

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Scott Harfield

Brighton, Sussex, BN2 5BE, United Kingdom

Location

MeSH Terms

Conditions

Glioblastoma; Radiation Injuries

Interventions

Magnetic Resonance Spectroscopy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cressida Lorimer, MD

  Brighton and Sussex NHS Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 4, 2023
• Study Start: August 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)