Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
Patients with surgically removed single brain metastasis are randomly allocated to control
or experimental arm. Before treatment the MRC Neurological Status Scale is used for
assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and
Mini-Mental State Examination to assess cognitive functioning. The control group receive
30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the
experimental arm are treated with stereotactic radiotherapy to the resection cavity. The
dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study
hypothesis is that the difference in the 5-months failure free survival rate isn't higher
than 25% in experimental arm compared to control arm.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
5 months after radiotherapy
Lucyna Kepka, Prof.
M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
Poland: Ministry of Science and Higher Education