Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009). The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases. The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Stereotactic hypofractionated radiation therapy delivered as follows: * Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI. * Planning tumor volume (PTV) equals GTV plus 3mm margin. * The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days. * RT to begin in a maximum of 2 weeks after randomization
Stereotactic hypofractionated radiation therapy delivered as follows: * Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI. * Planning tumor volume (PTV) equals GTV plus 3mm margin. * The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days. * RT to begin in a maximum of 2 weeks after randomization.
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
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 attributable to other causes other than the tumor or reduction in corticosteroid dose
Time frame: from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months
overall survival
Time frame: from date of randomization until death from any cause, assessed up to 48 months
local control
Time frame: from date of randomization until date of local progression, assessed up to 48 months
toxicity
* toxicity scored by the Common Terminology of Adverse Events version 4 * will be assessed every 2 months or in case of patient hospitalization or visit to the E.R.
Time frame: from date of randomization until death, assessed up to 48 months
quality of life
* quality of life measured by the "FACT Br" questionary * will be assessed every 2 months
Time frame: from date of randomization until last follow-up, assessed up to a period of 48 months
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