In this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses
used in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole
difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued
at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in
4 weeks. The adjuvant component of TMZ remains unchanged from current standard practice.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of patients completing the study treatment
To determine overall survival.
At one year
No
Canada: Health Canada Therapeutic Products Directorate
GEN-08-013
NCT01702610
December 2008
December 2013
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