Investigating the potential clinical benefit of Selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy (SEL-I-METRY): protocol for a multicentre UK single arm phase II trial

Table 2 Minimum schedule of assessments (SPIRIT diagram)

	Baseline		Treatment				End of Treatment	Follow Up
	Within 14 days prior to registration	Within 28 days of registration	Selumetinib			I-131 Therapy	30 days post end of Selumetinib treatment	3 monthly for first 12 months then 6 monthly for duration of trial^b
	Within 14 days prior to registration	Within 28 days of registration	Day 1	Day 14	Day 28	I-131 Therapy	30 days post end of Selumetinib treatment
Informed consent	X
Patient details (initials, date of birth, sex)	X
Medical History	X
Physical Examination/Vital signs	X		X	X	X		X	X
Ophthalmologic assessment	X
12-Lead ECG	X		X				X
Laboratory tests	X		X	X	X		X	X
Pregnancy test	X		X			X	X	X^c
Echocardiography /MUGA	X		X
Dispensing of Selumetinib			X
Tissue collection		X
CT neck, thorax, abdomen and pelvis	X^a							X
I-123 SPECT/CT		X			X
SPECT/CT for Lesion Dosimetry post I-131 therapy						X
Adverse Events	X		X	X	X	X	X	X^d
Concomitant Medications	X		X	X	X		X
Quality of life (QLQ-C30, QLQ-H&N35 and EQ-5D™)		X					X	X^e
Protein bound iodine blood sample collection						X^f
Cell-free DNA blood sample collection			X	X	X		X	X^g

^aif CT scans have not been performed within 28 days of starting treatment, an additional CT neck, chest, abdomen, and pelvis must be performed to enable assessment of response and progression-free survival as per RECIST criteria
^bParticipants who do not proceed to radioiodine therapy will be followed up for safety purposes until 30 days after completion of Selumetinib treatment only
^cPregnancy test to be done at the first and second 3 monthly follow up visits (3 month and 6 month follow-up)
^dAdverse reactions only at follow up visits
^eQuality of life is assessed at baseline, end of treatment and 3 monthly for the first 12 months of follow-up
^fCollected 24 and 144 h following I-131 dosing
^g3 and 6 months only

ISSN: 1471-2407