A multicentre prospective, interventional, randomised trial of PREOPerative radiosurgery compared with postoperative stereotactic radiotherapy for resectable brain metastases (PREOP-2)
Main Study PI (Switzerland)
Dr. Dr. Susanne Rogers
Kantonsspital Aarau, Aarau, Switzerland
susanne.rogers@ksa.ch
Study PI (Germany)
Prof. Dr. med. Michael Synowitz
University Medical Center Schleswig-Holstein, Campus Kiel
Michael.Synowitz@uksh.de
Study design:
● Multi-center, international, randomized, prospective, interventional 2-arm phase III study
Inclusion criteria:
● Confirmed cancer diagnosis Brain metastasis < 3 other brain metastases for single or multiple fraction radiosurgery No contraindication for MRI
Sample size:
●160 patients needed, target 200 due to competing risks
Endpoints:
● Primary endpoint: Incidence of leptomeningeal relapse at 12 months
● Secondary endpoint: Overall survival, neurological death, local control, quality of life
● Exploratory endpoints: Time to radiosurgery, time to neurosurgery, possible biomarker study
Trial registration
NCT05124236 https://www.clinicaltrials.gov/ct2/show/NCT05124236
Flowchart
