Table 1.

SPIRIT table

Study period
	Screening −60dM1D1	Baseline −14dM1D1	Intervention	End of radiotherapy	3 months post-irradiary	5 months post-irradiary	1 year post-irradiary	2, 5, 10 and 15 years post-irradiary
Enrolment
Eligibility screen	X
Informed consent	X
Allocation	X*
Interventions
Radiotherapy			X
Assessments
Physical examination	(X)†	X		X	X	X	X
Neurological evaluation: NANO score	(X)†	X		X	X	X	X	X
General condition: ECOG status, KPS score	X	X		X	X	X	X	X
PROMs		X				X	X	X
Web-based cognitive screening: CANTAB		X				X		X
Neuropsychological testing‡		X‡				X‡		X‡
Radiological assessment: RANO						X	X	X
Basal endocrinological status	(X)†	X			X	X	X	X
Concomitant medication (eg, corticosteroid and AED dose)	(X)†	X		X	X	X	X	X
Epilepsy/seizure control	(X)†	X		X	X	X	X	X
AESI		X		X	X	X	X	X
AE and SAE		X		X	X	X	X

*Allocation after the patient is deemed eligible for inclusion and signed informed consent form is collected.

†Optional at enrolment, repeated at baseline if >14 days to start of radiotherapy.

‡Norwegian and some Swedish patients only.

AE, adverse event; AED, anti-epileptic drug; AESI, adverse event of special interest; CANTAB, CAmbridge Neuropsychological Test Automated Battery; −14dM1D1, maximum 14 days prior to radiotherapy; −60dM1D1, maximum 60 days prior to radiotherapy; ECOG, Eastern Cooperative Oncology Group; KPS, Karnofsky Performance Status; NANO, Neurological Assessment in Neuro-Oncology; PROMs, patient-reported outcome measures; RANO, Response Assessment in Neuro-Oncology; SAE, serious adverse event; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.