Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study
Patients in good general condition with resectable 1-3 brain metastases will be randomized
to surgery and whole brain radiotherapy and whole brain radiotherapy and radiosurgery.
Initially we will evaluate the feasibility of carrying out the study with 15 patients in
each arm, and after, we will follow with the primary end-point of comparing the toxicity of
the exclusively radiotherapy arm with complications of the surgical arm. As a secondary
end-point, we will evaluate local recurrence-free survival, overall survival, distance
cerebral relapse-free survival (metachronous brain metastasis), free of neurological
progression survival, free of neurological death survival, free of dependent life (another
person)survival , steroid-free survival and quality of life.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
One year after the start of patient recruitment, the study will be analyzed for feasibility and, if feasible, we will pursue the study with primary end-point of comparing the toxicity of exclusive radiation therapy arm with the surgical arm.
Ricardo A Nakamura, MD
Barretos Cancer Hospital
Brazil: National Committee of Ethics in Research