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Table 1 Dose levels for the phase I part of the OLA-TMZ-RTE trial

From: Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable or partially resectable glioblastoma: OLA-TMZ-RTE-01 trial protocol

DL (Dose Level)

Olaparib (orally)

STUPP protocol

Temozolomide

IMRT

Each treatment will start on a Monday

DL0

50 mg Q12H, Monday to Tuesday

• 75 mg/m2/day until end of IMRT

• 4 weeks after the end of IMRT: 6 cycles of temozolomide at the dose of 150 mg/m2/day on days 1 to 5 every 28 days

• IMRT will begin at day 1

• Prescription doses will be 60Gy/30fr/6 weeks

• The PTV receives 95 to 107% of the prescribed dose

DL1 (starting dose level)

50 mg Q12H, Monday to Wednesday

DL2

100 mg Q12H, Monday to Wednesday

DL3

100 mg Q12H, Monday to Friday

DL4

200 mg Q12H, Monday to Wednesday

DL5

200 mg Q12H, Monday to Friday

DL6

200 mg Q12H, continuously