The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.
Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume
Centre Jean Perrin
Clermont-Ferrand, France
Institut Claudius Regaud
Toulouse, France
Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy
Time frame: time of study
Objective response rate (RECIST and volumetric criteria)
Time frame: time of study
Median survival, 6 month and 1 year survival rates
Time frame: 6 month and 1 year
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters
Time frame: time of study
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