A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma

Table 1 Schedule of assessments

Investigation	Screening /Baseline	Wk 1	Wk2	Wk3	Wk4	Wk5	Wk6	Wk7	Wk9	Wk13	Wk17	Wk 19	Wk 21, 25, 29, 33, 37, 41	Wk 27	Months post treatment 2,4,6,8,10,12,15,18,21,24,30,36,42,48,54,60
Informed consent	x
Histological confirmation of SCC	x
Repeat biopsy (skin or lymph nodes]			× ¹
Medical history	x⁶
Physical examination (ECOG, vital signs, toxicity]	x⁶	x	x	x	x	x	x	x	x	x	x		x		x
Concomitant meds	x
Urine analysis	x
Pregnancy test	x⁶
FBC	x⁶	x	x	x	x	x	x	x	x	x	x		x		x⁴
U&E, LFT’s	x⁶	x	x	x	x	x	x	x	x	x	x		x		x⁴
Coagulation profile, TSH, hep, HIV
x
FDG PET	x⁷											x		x²
CXCR4 PET /CT	x³			x
Contrast CT / MRI	x⁷											x⁴
Disease status		x	x	x	x	x	x	x	x	x	x		x		x
Blood	x			x						x			x⁵

¹Not mandatory
²If week 19 FDG PET is equivocal
³Pretreatment
⁴If clinically indicated
⁵Weeks 21 and 37 only
⁶Due within 14 days of trial registration
⁷Due within 28 days of trial registration
Patients who are considered treatment failures will be followed at the above time points for survival only. This may be done at clinic visits when seen for ongoing treatment or by telephone call

ISSN: 1748-717X