Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
progression free survival
progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as: increase in 25% of the product of perpendicular diameters of enhancing lesions significant increase in T2/Flair non enhancing component appearance of new lesions clinical deterioration not atributable to other causes other than the tumor or reduction in corticosteroid dose
from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months
Andre T Chen, M.D.
Hospital das Clinicas da Faculdade de Medicina da USP
Brazil: National Committee of Ethics in Research