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dc.contributor.authorHafeez, Sen_US
dc.contributor.authorPatel, Een_US
dc.contributor.authorWebster, Aen_US
dc.contributor.authorWarren-Oseni, Ken_US
dc.contributor.authorHansen, Ven_US
dc.contributor.authorMcNair, Hen_US
dc.contributor.authorMiles, Een_US
dc.contributor.authorLewis, Ren_US
dc.contributor.authorHall, Een_US
dc.contributor.authorHuddart, Ren_US
dc.date.accessioned2020-05-28T10:10:48Z
dc.date.issued2020-05-26en_US
dc.identifier.citationBMJ open, 2020, 10 (5), pp. e037134 - ?en_US
dc.identifier.issn2044-6055en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3644
dc.identifier.eissn2044-6055en_US
dc.identifier.doi10.1136/bmjopen-2020-037134en_US
dc.description.abstractINTRODUCTION:Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for standard radical treatment with cystectomy or daily radiotherapy present a large unmet clinical need. Untreated, they suffer high cancer specific mortality and risk significant disease-related local symptoms. Hypofractionated radiotherapy (delivering higher doses in fewer fractions/visits) is a potential treatment solution but could be compromised by the mobile nature of the bladder, resulting in target misses in a significant proportion of fractions. Adaptive 'plan of the day' image-guided radiotherapy delivery may improve the precision and accuracy of treatment. We aim to demonstrate within a randomised multicentre phase II trial feasibility of plan of the day hypofractionated bladder radiotherapy delivery with acceptable rates of toxicity. METHODS AND ANALYSIS:Patients with T2-T4aN0M0 MIBC receiving 36 Gy in 6-weekly fractions are randomised (1:1) between treatment delivered using a single-standard plan or adaptive radiotherapy using a library of three plans (small, medium and large). A cone beam CT taken prior to each treatment is used to visualise the anatomy and select the most appropriate plan depending on the bladder shape and size. A comprehensive radiotherapy quality assurance programme has been instituted to ensure standardisation of radiotherapy planning and delivery. The primary endpoint is to exclude >30% acute grade >3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received >1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2). Secondary endpoints include local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning. Target recruitment is 62 patients. ETHICS AND DISSEMINATION:The trial is approved by the London-Surrey Borders Research Ethics Committee (13/LO/1350). The results will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities. TRIAL REGISTRATION NUMBER:NCT01810757.en_US
dc.formatElectronicen_US
dc.format.extente037134 - ?en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.titleProtocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance.en_US
dc.typeJournal Article
dcterms.dateAccepted2020-03-29en_US
rioxxterms.versionofrecord10.1136/bmjopen-2020-037134en_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0en_US
rioxxterms.licenseref.startdate2020-05-26en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfBMJ openen_US
pubs.issue5en_US
pubs.notesNot knownen_US
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/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.publication-statusPublisheden_US
pubs.volume10en_US
pubs.embargo.termsNot knownen_US
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamICR-CTSU Urology and Head and Neck Trials Teamen_US
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
dc.contributor.icrauthorHall, Emmaen_US
dc.contributor.icrauthorHafeez, Shaistaen_US
dc.contributor.icrauthorLewis, Rebeccaen_US
dc.contributor.icrauthorHuddart, Roberten_US


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