Table 2 Study procedures
Screening before inclusion | Baseline assessment (within 6 weeks before radiotherapy start) | During radiotherapy period (7 weeks) for 3 cohorts: - Cohort IMRT - Cohort SRT - Cohort PRT | End of radiotherapy | AFTER THE END of radiotherapy | ||
|---|---|---|---|---|---|---|
6 and 12 months | Yearly up to 10 years | |||||
Study explanation and signed informed consent before any study procedures | ✓ | |||||
Patients | ||||||
Standard physical and neurological examination (Nano-scale) | ✓ | ✓ Weekly during radiotherapy | ✓ | ✓ | ||
Cognitive assessment (by a trained neuropsychologist): - Executive functions - Episodic memory - Working memory - Short-term memory - Attention/Information processing speed - Prospective memory (Mem-Pro Clinic) | ✓ | ✓ | ✓ (at 3, 5, 7 and 10 years only) | |||
Brain MRI (standard follow-up):3DT1w, Diffusion (b = 0 and b = 1000 s.mm-2, 30 directions), Perfusion (Dynamic Susceptibility Contrast, DSC-MRI), 3DT1 Gadolinium, 3D Fluid Attenuated Inversion Recovery (FLAIR), Angiographic “time of flight” sequence (TOF) | ✓ | ✓ | ✓ | |||
Cognitive complaints, anxiety and depression assessment Fact-Cog - HADS MFI | ✓ | ✓ | ✓ | |||
Quality-of-life assessment - EORTC QLQC30 + BN20 | ✓ | ✓ | ✓ | |||
Evaluation of the socio-professional reintegration | ✓ | ✓ | ✓ | |||
At the discretion of the investigator: Endocrinological, ophthalmological and audiometric evaluations | ✓ | ✓ (12 months only) | ✓ | |||
OPTIONAL | ||||||
Blood sample banking | ✓ | ✓ | ✓ | ✓ | ||
Participants free of brain disease | ||||||
Baseline assessment (within 6 weeks before radiotherapy start) | 6 and 12 months | Yearly up to 10 years | ||||
Cognitive assessment (by a trained neuropsychologist): - MoCA - Executive functions - Episodic memory - Working memory - Short-term memory - Attention/Information processing speed - Prospective memory (Mem-Pro Clinic) | ✓ | ✓ | ✓ (at 3, 5, 7 and 10 years only) | |||
Cognitive complaints, anxiety and depression assessment Fact-Cog - HADS - MFI | ✓ | ✓ | ✓ | |||
Quality-of-life assessment - EORTC QLQC30 | ✓ | ✓ | ✓ | |||