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 | ✓ | ||||||||||||||||||||||||||