Radiation therapy before radical cystectomy combined with immunotherapy in locally advanced bladder cancer – study protocol of a prospective, single arm, multicenter phase II trial (RACE IT)

Table 2 Flowchart for minimum assessments of treatment and follow up phase

	Study Phase	Screening	Treatment visit	Treatment visit	Treatment visit	Treatment visit	Treatment visit		Postop visit	Postop visit	Follow up visit	Follow up visit
	Therapy		Nivolumab cycle 1	Nivolumab cycle 2	Nivolumab cycle 3	Nivolumab cycle 4	End RIT/PreOP		Postop 6w	Postop 12w	Follow up 6 m postop	Follow up 12 m postop
	Timepoint	-d28 – d0	d1 (w1d1)	d15 (w3d1)	d29 (w5d1)	d43 (w7d1)	d64 (w10d1)		w17–21	w23–27	w37–41	w63–67
Procedures	Visit No	1	2	3	4	5	6		7	8	9	10
Informed Consent		X						Radical Cystectomy week 11–15
Inclusion/Exclusion Criteria		X
Medical History		X
Prior cancer therapy		X
ECOG/Performance Status		X	X	X	X	X	X		X	X	X	X
Physical Examination		X	X	X	X	X	X		X	X	X	X
Vital Signs		X	X	X	X	X	X		X	X
Height/Weight		X	X	X	X	X	X		X	X
Symptom/Adverse Event Assessment		X	X	X	X	X	X		X	X	X	X
Bladder/surgery specific AEs		X	X	X	X	X	X		X	X	X	X
Concomitant Medication		X	X	X	X	X	X		X	X
Laboratory tests		X	X	X	X	X	X		X	X	X	X
HIV/Hepatitis test		X							X
Pregnancy test (Serum)		X					X
Urine analysis		X					X		X	X	X	X
Kidney Ultrasound		X							X	X	X	X
Imaging (CT/MRT)		X					X				X	X
Histology assessment		X							X
QoL-Questionnaires		X					X			X	X	X
Exploratory biomarker blood draw		X					X			X
Survival status									X	X	X	X
Review of subsequent therapy									X	X	X	X

ISSN: 1471-2407