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@article{Battersby:2017:10.1186/s13063-017-2085-2,
author = {Battersby, NJ and Dattani, M and Rao, S and Cunningham, D and Tait, D and Adams, R and Moran, BJ and Khakoo, S and Tekkis, P and Rasheed, S and Mirnezami, A and Quirke, P and West, NP and Nagtegaal, I and Chong, I and Sadanandam, A and Valeri, N and Thomas, K and Frost, M and Brown, G},
doi = {10.1186/s13063-017-2085-2},
journal = {Trials},
title = {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},
url = {http://dx.doi.org/10.1186/s13063-017-2085-2},
volume = {18},
year = {2017}
}

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TY  - JOUR
AB  - Background:Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy.Methods/design:TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis.Discussion:The TRIGGER trial aims to determine whether patients with locally advanced
AU  - Battersby,NJ
AU  - Dattani,M
AU  - Rao,S
AU  - Cunningham,D
AU  - Tait,D
AU  - Adams,R
AU  - Moran,BJ
AU  - Khakoo,S
AU  - Tekkis,P
AU  - Rasheed,S
AU  - Mirnezami,A
AU  - Quirke,P
AU  - West,NP
AU  - Nagtegaal,I
AU  - Chong,I
AU  - Sadanandam,A
AU  - Valeri,N
AU  - Thomas,K
AU  - Frost,M
AU  - Brown,G
DO  - 10.1186/s13063-017-2085-2
PY  - 2017///
SN  - 1745-6215
TI  - 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
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-017-2085-2
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000408676700002&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/57568
VL  - 18
ER  -

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