| Baseline | Treatment | Follow-up after |
---|
Assessmenta | | | 1 M | 3 M | 6 M | Every 3 M thereafter | Every 6 M thereafter |
---|
Medical history | ✓ | | | | | | |
Physical examination | ✓ | | ✓ | ✓ | ✓ | ✓ | |
CT or PET-CTb | ✓ | | | | | | |
KPS | ✓ | | ✓ | ✓ | ✓ | ✓ | |
JCS | ✓ | | ✓ | ✓ | ✓ | ✓ | |
MMSE | ✓ | | | | ✓ | | ✓ |
Brain MRI | ✓ | | ✓ | ✓ | ✓ | ✓ | |
Adverse events | | ✓ | ✓ | ✓ | ✓ | ✓ | |
- Footnotes: M Months, CT Computed tomography, PET-CT 18F-fluorodeoxyglucose positron emission tomography-computed tomography, KPS Karnofsky performance status, JCS Japan Coma Scale, MMSE Mini mental status examination, MRI Magnetic resonance imaging
- aExtra imaging outside of the study schedule is allowed per the discretion of the physician
- bEither enhanced CT or PET-CT is required