{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,19]],"date-time":"2026-04-19T07:45:24Z","timestamp":1776584724040,"version":"3.51.2"},"reference-count":23,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2020,5,24]],"date-time":"2020-05-24T00:00:00Z","timestamp":1590278400000},"content-version":"unspecified","delay-in-days":23,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000289","name":"Cancer Research UK","doi-asserted-by":"publisher","award":["CRUK\/12\/055"],"award-info":[{"award-number":["CRUK\/12\/055"]}],"id":[{"id":"10.13039\/501100000289","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,4,21]]},"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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 \u2018plan of the day\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      Patients with T2-T4aN0M0 MIBC receiving 36\u2009Gy 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\n                      <jats:underline>&gt;<\/jats:underline>\n                      30% acute grade\n                      <jats:underline>&gt;<\/jats:underline>\n                      3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received\n                      <jats:underline>&gt;<\/jats:underline>\n                      1 fraction (p0=0.7, p1=0.9, \u03b1=0.05, \u03b2=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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT01810757\">NCT01810757<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-037134","type":"journal-article","created":{"date-parts":[[2020,5,27]],"date-time":"2020-05-27T06:26:09Z","timestamp":1590560769000},"page":"e037134","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct01810757","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct01000129","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2057-0946","authenticated-orcid":false,"given":"Shaista","family":"Hafeez","sequence":"first","affiliation":[{"name":"Radiotherapy and Imaging, The Institute of Cancer Research, London, UK"},{"name":"Radiotherapy and Imaging, The Royal Marsden Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Patel","sequence":"additional","affiliation":[{"name":"Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Webster","sequence":"additional","affiliation":[{"name":"Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karole","family":"Warren-Oseni","sequence":"additional","affiliation":[{"name":"Radiotherapy and Imaging, The Institute of Cancer Research, London, UK"},{"name":"Radiotherapy and Imaging, The Royal Marsden Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vibeke","family":"Hansen","sequence":"additional","affiliation":[{"name":"Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"McNair","sequence":"additional","affiliation":[{"name":"Radiotherapy and Imaging, The Institute of Cancer Research, London, UK"},{"name":"Radiotherapy and Imaging, The Royal Marsden Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Miles","sequence":"additional","affiliation":[{"name":"Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca","family":"Lewis","sequence":"additional","affiliation":[{"name":"Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Hall","sequence":"additional","affiliation":[{"name":"Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Huddart","sequence":"additional","affiliation":[{"name":"Radiotherapy and Imaging, The Institute of Cancer Research, London, UK"},{"name":"Radiotherapy and Imaging, The Royal Marsden Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,5,26]]},"reference":[{"key":"2025121300072868000_10.5.e037134.1","unstructured":"National Institute for Health and Clinical Excellence (NICE) Guidance . 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