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dc.contributor.authorBattersby, NJ
dc.contributor.authorDattani, M
dc.contributor.authorRao, S
dc.contributor.authorCunningham, D
dc.contributor.authorTait, D
dc.contributor.authorAdams, R
dc.contributor.authorMoran, BJ
dc.contributor.authorKhakoo, S
dc.contributor.authorTekkis, P
dc.contributor.authorRasheed, S
dc.contributor.authorMirnezami, A
dc.contributor.authorQuirke, P
dc.contributor.authorWest, NP
dc.contributor.authorNagtegaal, I
dc.contributor.authorChong, I
dc.contributor.authorSadanandam, A
dc.contributor.authorValeri, N
dc.contributor.authorThomas, K
dc.contributor.authorFrost, M
dc.contributor.authorBrown, G
dc.date.accessioned2017-10-24T10:03:53Z
dc.date.issued2017-08-29
dc.identifier.citationTrials, 2017, 18 (1), pp. 394 - ?
dc.identifier.issn1745-6215
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/862
dc.identifier.eissn1745-6215
dc.identifier.doi10.1186/s13063-017-2085-2
dc.description.abstractBackground 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 rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection.Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016.
dc.formatElectronic
dc.format.extent394 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectAdenocarcinoma
dc.subjectRectal Neoplasms
dc.subjectNeoplasm Recurrence, Local
dc.subjectDisease Progression
dc.subjectMagnetic Resonance Imaging
dc.subjectDisease-Free Survival
dc.subjectTreatment Outcome
dc.subjectClinical Protocols
dc.subjectNeoadjuvant Therapy
dc.subjectColostomy
dc.subjectFeasibility Studies
dc.subjectPredictive Value of Tests
dc.subjectResearch Design
dc.subjectTime Factors
dc.subjectQuality of Life
dc.subjectCost-Benefit Analysis
dc.subjectHealth Care Costs
dc.subjectIntention to Treat Analysis
dc.subjectNeoplasm Grading
dc.subjectChemoradiotherapy, Adjuvant
dc.titleA 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.
dc.typeJournal Article
dcterms.dateAccepted2017-07-03
rioxxterms.versionofrecord10.1186/s13063-017-2085-2
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2017-08-29
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfTrials
pubs.issue1
pubs.notesNo embargo
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Ashworth Collaborators
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Gastrointestinal Cancer Biology and Genomics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Systems and Precision Cancer Medicine
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Ashworth Collaborators
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Gastrointestinal Cancer Biology and Genomics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Systems and Precision Cancer Medicine
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume18
pubs.embargo.termsNo embargo
icr.researchteamMedicine (RMH Smith Cunningham)en_US
icr.researchteamAshworth Collaboratorsen_US
icr.researchteamGastrointestinal Cancer Biology and Genomicsen_US
icr.researchteamSystems and Precision Cancer Medicineen_US
dc.contributor.icrauthorBrown, Ginaen
dc.contributor.icrauthorValeri, Nicolaen
dc.contributor.icrauthorCunningham, Daviden
dc.contributor.icrauthorChong, Yu-Shingen
dc.contributor.icrauthorSadanandam, Angurajen
dc.contributor.icrauthorMarsden,en


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