Randomised trial of adjuvant versus delayed stereotactic radiotherapy to resection cavity of brain metastases and quality of life outcomes

Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 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 CONDITION: Brain metastases PRIMARY OUTCOME: Health‐related quality of life ; ; Instrument: EORTC QLQ‐C30 and Brain Cancer Module BN‐20; raw scores transformed to scaled scores ranging 0‐100 SECONDARY OUTCOME: Distant intracranial control rate ; ; Defined as recurrence of disease a distance of >1 cm from previously resected brain metastases on brain imaging (MRI brain preferred) Local (resected metastases) control rate ; ; Defined as recurrence of disease within 1 cm of resected brain metastases on brain imaging (MRI brain preferred) Neurocognitive function ; ; Instrument: measured by a battery of tests assessing different aspects of neurocognition such as memory, attention, processing speed, executive function and verbal fluency. ; Overall survival ; ; Measured from the date of randomisation to the date of death. 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
Epistemonikos ID: 4848ceb0b187c6c2c3b541562727bccf41f18aac
First added on: Aug 23, 2024