This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD
Observation till Progression then rechallenging with TMZ
Cliniques Universitaires Saint-Luc
Brussels, Europe, Belgium
RECRUITINGto determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
Time frame: 36 months
safety and adverse event profile of prolonged adjuvant Temozolomide
Time frame: 3 years
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