A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B

Autor: Patrick E J Hanssens, Margriet M. Sitskoorn, Karin Gehring, Eline Verhaak, Wietske C. M. Schimmel
Přispěvatelé: Cognitive Neuropsychology
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Gamma knife radiosurgery
Quality of life
Adult
Cancer Research
Pediatrics
medicine.medical_specialty
medicine.medical_treatment
Brain Neoplasms/radiotherapy
Neuropsychological Tests
Radiosurgery
lcsh:RC254-282
Cognitive functioning
Neuropsychological assessment
law.invention
03 medical and health sciences
Study Protocol
Young Adult
0302 clinical medicine
Cognition
Randomized controlled trial
law
Genetics
Clinical endpoint
medicine
Hopkins verbal learning test
Humans
Cognitive skill
Prospective Studies
Stereotactic radiosurgery
medicine.diagnostic_test
Radiotherapy
business.industry
Brain Neoplasms
Antineoplastic Protocols
Brain metastases
Neuropsychological test
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
3. Good health
Cognitive test
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Whole brain radiation therapy
business
030217 neurology & neurosurgery
Zdroj: BMC Cancer
BMC Cancer, 18:218. BioMed Central Ltd.
BMC Cancer, Vol 18, Iss 1, Pp 1-9 (2018)
ISSN: 1471-2407
Popis: Gamma Knife radiosurgery (GKRS) is increasingly applied in patients with multiple brain metastases and is expected to have less adverse effects in cognitive functioning than whole brain radiation therapy (WBRT). Effective treatment with the least negative cognitive side effects is increasingly becoming important, as more patients with brain metastases live longer due to more and better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple brain metastases that include objective neuropsychological testing. CAR-Study B is a prospective randomised trial comparing cognitive outcome after GKRS or WBRT in adult patients with 11–20 newly diagnosed brain metastases on a contrast-enhanced MRI-scan, KPS ≥70 and life expectancy of at least 3 months. Randomisation by the method of minimization, is stratified by the cumulative tumour volume in the brain, systemic treatment, KPS, histology, baseline cognitive functioning and age. The primary endpoint is the between-group difference in the percentage of patients with significant memory decline at 3 months. Secondary endpoints include overall survival, local control, development of new brain metastases, cognitive functioning over time, quality of life, depression, anxiety and fatigue. Cognitive functioning is assessed by a standardised neuropsychological test battery. Assessments (cognitive testing, questionnaires and MRI-scans) are scheduled at baseline and at 3, 6, 9, 12 and 15 months after treatment. Knowledge gained from this trial may be used to inform individual patients with BM more precisely about the cognitive effects they can expect from treatment, and to assist both doctors and patients in making (shared) individual treatment decisions. This trial is currently recruiting. Target accrual: 23 patients at 3-months follow-up in both groups. The Netherlands Trials Register number NTR5463. ClinicalTrials.gov registration number NCT02953717 , first received October 27, 2016, 8 patients were enrolled in this study on 31 July 2017.
Databáze: OpenAIRE
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