1758-1759 / 2437
•
Newly diagnosed
glioblastoma
•
KPS > 70
•
Eligible for
standard treatment
1 2 3 4 5 6 7
-1
8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34
weeks
1 2 3 4 5 6 7
-1
8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34
weeks
Radiotherapy
5x per week (total dose of 60 Gy in 30 fractions)
Temozolomide
75 mg/m
2
p.o. for 6 weeks (during radiotherapy), followed (after a 4 weeks’ interval)
by up to 6 cycles of maintenance TMZ chemotherapy 150-200 mg/m
2
p.o., days 1-5 out of 28 days
Marizomib
0.8 mg/m2 .v. at days 1, 8, 15, 29 and 36 during radiotherapy, followed
(after a 4 weeks’ interval)
by adjuvant treatment at days days 1, 8, and 15 of a 28 day cycle until disease progression, unacceptable
toxicity or withdrawal of consent
Stratification factors
:
• ≤55 vs. >55 years
• KPS 70/80 vs. 90/100
• Biopsy/partial vs. complete resection
• Institution
EORTC 1709
no placebo