Table 1.
Flowchart of enrolment, interventions and assessments
Staging | Therapy | Follow-up | ||||||
---|---|---|---|---|---|---|---|---|
T0 | Start | End | T1 | T2 | T3 | T4 | T5 – Tx | |
1 week before RT (day − 6 until day 0) | Day 1 of RT | Day 12 of RT | 6 weeks after RT (+/− 7 days) | 3 months after RT (+/− 10 days) | 9 months after RT (+/− 10 days) | 18 months after RT (+/− 10 days) | every 12 months, starting at 30 months after RT (+/− 28 days) | |
Check of in−/ exclusion criteria | X | |||||||
Patient information, informed consent | X | |||||||
Registration | X | |||||||
Randomization | X | |||||||
TREATMENT PLANNING AND IMAGE ACQUISITION | ||||||||
Planning of Radiotherapy | X | |||||||
Upload of planning CT and structure sets | X | |||||||
Upload of MR images | X | X | X | X | X | X | ||
DOCUMENTATION | ||||||||
Documentation of demographic data and medical history | X | |||||||
Clinical, neurological examination | X | X | X | X | X | X | X | |
Documentation of medication | X | X | X | X | X | X | X | |
Documentation of adverse events | X | X | X | X | X | X | ||
ASSESSMENT OF TARGET VARIABLES | ||||||||
NCF Assessment (VLMT, WMS-R-Digit Spans, TMT-A /−B) | X | X | X | X | X | |||
Depression Assessment (HADS-D) | X | X | X | X | X | |||
QoL Assessment (QLQ-C15-PAL/−BN20, SEIQoL-Q) | X | X | X | X | X | |||
Study-specific MRI | X | X | X | X | X |