The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate. The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
complete response
defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids
Time frame: through study completion, 2 years
partial response
defined by at least 50% diminution of tumor size, evaluated by the product of 2 perpendicular diameters measured by MRI, with stability or amelioration of neurological status of patient receiving stable or reduced corticoid doses
Time frame: through study completion, 2 years
stabilization
corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses
Time frame: through study completion, 2 years
progression
defined by increase of at least 25% of tumor size and/or a second brain localization in MRI, with degradation of neurological status of patient
Time frame: through study completion, 2 years
global survival
Time frame: through study completion, 2 years
treatment tolerance
evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)
Time frame: through study completion, 2 years
survival without tumor recurrence
tumor recurrence detected with radiology examination
Time frame: through study completion, 2 years
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life quality
evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)
Time frame: through study completion, 2 years