Table 2.

Overview of study assessments of the OLA-TMZ-RTE-01 trial

	Screening/Baseline	Radiotherapy period											Maintenance period (TMZ + Olaparib)													Post-treatment Visite	Follow up every 2 months
		IMRT						Treatment break					Cycle 1				Cycle 2				Cycle 3 to 6				Olaparib maintenance
Week (W)		W 0	W 1	W 2	W 3	W 4	W 5	W 6	W 7	W 8	W 9	W 10	W 11	W 12	W 13	W 14	W 15	W 16	W 17	W 18	W 19	W 23	W 27	W 31	W 35
Day	(−28 to −1)	1	8	15	22	29	36	43	50	57	64	71	78	85	92	99	106	113	120	127	134	162	190	218	246
Informed consent	✓
Medical history and demographic	✓
Initial histology	✓
Prior/ concomitant medication (corticosteroid)	✓			✓
Adverse event evaluation	✓			✓
Contrast enhanced MRI	✓								✓				✓								✓a		✓a		✓a	✓a	✓a
Ancillary spectro-MRIb	✓								✓				✓								✓a		✓a		✓a	✓a	✓a
Dosimetric Brain CT-scan	✓
Neurological assessment	✓	✓	✓	✓	✓	✓	✓	✓	✓				✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓ d
Physical examination, weight, vital signs	✓	✓	✓	✓	✓	✓	✓	✓	✓				✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Performance status OMS	✓	✓	✓	✓	✓	✓	✓	✓	✓				✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
ECG	✓
Serum pregnancy test	✓
Hematology	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Fasting blood chemistry	✓	✓		✓		✓		✓	✓		✓		✓		✓		✓		✓		✓c	✓c	✓c	✓c	✓c	✓
Coagulation (INR, aPTT)	✓
Urinalysis	✓
Ancillary biomarker explorationb -biopsy of primitive tumor -blood sample	✓
Cognition and Quality of Life (QoL)
-MoCA EORTC QLQ-C30 + BN20	✓												✓										✓d
-Ancillary assessmentsb	✓												✓										✓d
Radiation (IMRT)			2Gy*5 days/week for 6 weeks
Temozolomide			75 mg/m2 daily from first to last day of IMRT										5 days				5 days				5 days	5 days	5 days	5 days
Olaparib			Cf dose level						Cf dose level
Drug accountability			✓	✓	✓	✓	✓	✓					✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Morbidity, survival		✓

^a Every 8 weeks

^b For voluntary patients and their caregivers with signed ancillary consents

^c Every 4 weeks

^d At Day 1 of cycle 5

^e For patients without disease progression