None listed
Conditions
Brief summary
The study aims to address whether the timing of stereotactic radiotherapy (SRT) after surgical removal of brain metastases impacts on quality of life; that is, whether treatment on local recurrence (disease returning at the surgical cavity) impacts on quality of life more than upfront SRT following resection of brain metastases. Who is it for? You may be eligible to participate in this study if you are aged 18 years or above and have had 1-4 brain metastases surgically removed. Study details: After surgical removal of brain metastases, in the absence of further treatment, about half of patients will develop a recurrence (disease returning) within the surgical cavity(s), while about half will not. For patients who had 1-4 brain metastases surgically removed, SRT targeting the surgical cavity(s) has been shown to provide local control rates of 70-90% at 1 year. Nevertheless, approximately 50% of patients are destined to never recur at the surgical cavity(s); hence close observation, with radiotherapy at the first sign of recurrence is also often practised. This approach spares treatment in potentially half of patients. By using regular 3-monthly MRIs of the brain, most recurrences should be detected while they are small and before symptoms develop. The study aims to address whether the timing of SRT after surgical removal of brain metastases impacts on quality of life. We are also studying the effect of treatment on patient’s neurocognitive function (memory, thinking processes). It is hypothesized that delivering SRT on local recurrence is no worse than upfront SRT to resection cavity in terms of patient’s quality of life.
Interventions
Observation with 3-monthly MRI brain surveillance (for 24 months, or until there is a clinical reason not to continue, whichever is earlier), and stereotactic radiotherapy on local recurrence following resection of brain metastases
Sponsors
William Buckland Radiotherapy Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age >/=18 years 2 Number of brain metastases – 1-4 brain metastases (as defined on the pre-operative MRI brain) and complete resection of the lesions on post-operative imaging performed within 4 weeks of surgery 3 Non-primary brain tumour site 4 ECOG performance status 0-3 5 Expected life expectancy of >6 months 6 Size of each resection cavity – resection cavity must measure < /=5.0 cm in maximal extent on the post-operative MRI obtained within 4 weeks post-surgery. 7 Tumour staging procedures – all standard tumour-staging procedures necessary to define baseline extra-cranial disease status completed < /=42 days prior to registration 8 Willing or able to complete health-related questionnaires by themselves and by a carer/proxy, if available 9 Willing and able to complete neurocognitive assessments
Exclusion criteria
1 More than 4 untreated brain metastases 2 Prior cranial radiation therapy 3 Leptomeningeal metastases 4 Inability to complete MRI brain 5 Known allergy to gadolinium 6 Remaining unresected brain metastases 7 Planned cytotoxic chemotherapy during stereotactic radiotherapy (SRT) 8 Other tumour types – primary germ cell tumour, small cell carcinoma, or lymphoma 9 Resected cavities unsuitable for SRT (eg. located < /= 2 mm from the optic chiasm) 10 Pregnant or lactating women 11 Men or women of childbearing potential who are unwilling to employ adequate contraception throughout study
Outcome results
None listed