Glioblastoma Cancer
Conditions
Interventions
All participants received an extra pre-treatment MRI scan and undertook a series of questionnaires at time points through their treatment. Study participants were eligible if they were receiving radio
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged >65 years with a new diagnosis of GBM. Diagnosis made via histological confirmation following biopsy or debulking surgery or radiologically during an MDM meeting confirmed by a consultant neuroradiologist. This lower age limit is due to previous clinical trials which have established gold-standard treatment regimes for patients under the age of 65 years. Patients aged 65 years 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. 2. Patients undergoing radiotherapy treatment to the brain for the treatment of their GBM 3. Patients able to undergo an MRI scan 4. Patients undergoing treatment at one of the study centres 5. Patients have the capacity to participate in the study 6. Patients with physical impairments that prevent them from filling in their questionnaires involved in the study may still participate if they are able to communicate their answers through a third party
Exclusion criteria
Exclusion criteria: 1. Patients not fit for radiotherapy treatment or having single-agent chemotherapy with no radiotherapy 2. Patients lacking capacity 3. Patients who do not have a sufficient grasp of the English language to be able to complete the questionnaires 4. Patients unable to communicate their responses to the questionnaires 5. Patients who are concurrently enrolled in a Clinical Trial of an Investigational Medicinal Product (CTIMP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a 10-point change in the EORCT QLQ C30 quality of life questionnaire (with the BN-20 brain and ELD14 elderly patient subsets of questions added) from baseline to 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The impact of side effects from cranial radiotherapy will also be assessed by: 1. MoCA cognitive screening questionnaire, scored as impaired (25), at baseline and at 8 weeks 2. Corticosteroid dose, recorded in milligrams at baseline and at 8 weeks 3. Treatment-associated toxicities of fatigue, headache, confusion, nausea, vomiting and seizures, measured using the Common Terminology Criteria for Adverse Events (CTCAE) at baseline and 8 weeks. Those scoring >3 will be recorded. 4. Overall survival, measured from the date of diagnosis (defined as the first imaging modality reviewed by a neuroradiology consultant within the multidisciplinary team meeting (MDM) setting which shows changes consistent with a GBM) until the date of death or censoring of the study 5. Progression-free survival, measured from the date of diagnosis (defined as the first imaging modality reviewed by a neuroradiology consultant within the MDM setting which shows changes consistent with a GBM) until the date of progression as confirmed by imaging reviewed by a neuroradiologist | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed