Whole-brain irradiation with hippocampal sparing and dose escalation on metastases: neurocognitive testing and biological imaging (HIPPORAD) – a phase II prospective randomized multicenter trial (NOA-14, ARO 2015–3, DKTK-ROG)

Table 1 Flowchart of enrolment, interventions and assessments

	Staging	Therapy		Follow-up
	T₀	Start	End	T₁	T₂	T₃	T₄	T₅ – T_x
	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

ISSN: 1471-2407