A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial

Table 3 Deferral of surgery follow-up protocol

Time line from end of CRT	Visit window	Clinic OPA^b	PROM^c	Scans	Endoscopy
6 months^a,d	±1 month	X		MRI	Flex sig
9 months^d	± 1 month	X		MRI	Flex sig
1 year^d	± 1 month	X	EORTC QLQ-C30, LARS, EQ-5D	MRI CT	Colonoscopy
1 year 3 months	± 1 month	X
1 year 6 months^d	± 1 month	X		MRI	Flex sig
1 year 9 months	± 1 month	X
2 years^e	± 1 month	X		MRI CT	Flex sig
2 years 6 months^e	± 1 month	X
3 years^d	± 2 months	X	EORTC QLQ-C30, LARS, EQ-5D	MRI CT	Flex sig
3 years 6 months	± 2 months	X
4 years^d	± 2 months	X		MRI	Flex sig
4 years 6 months	± 2 months	X
5 years^d	± 3 months	X	EORTC QLQ-C30, LARS, EQ-5D	MRI	Colonoscopy

^a This visit should take place once the patient has completed chemotherapy. It is recommended that a computed tomography (CT) scan is also performed following the completion of chemotherapy as is usual practice
^bEach clinic outpatient appointment (OPA) should include a digital rectal exam and CEA (tumour marker) blood test
^cQuality of life Case Record Form (CRF): EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, v3; LARS, Low Anterior Resection Syndrome Score; EQ-5D, EuroQol Group five dimensions Health Questionnaire
^dIf patient has consented to the additional blood sample collection for research (circulating tumour DNA and markers of cell proliferation and apoptosis) then samples collected during the clinic outpatient appointment, ideally at the same time as the routine blood tests are performed
CRT pre-operative chemoradiotherapy, Flex sig flexible sigmoidoscopy, PROM patient-reported outcome measure

ISSN: 1745-6215