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dc.contributor.authorHuddart, Ren_US
dc.contributor.authorHafeez, Sen_US
dc.contributor.authorLewis, Ren_US
dc.contributor.authorMcNair, Hen_US
dc.contributor.authorSyndikus, Ien_US
dc.contributor.authorHenry, Aen_US
dc.contributor.authorStaffurth, Jen_US
dc.contributor.authorDewan, Men_US
dc.contributor.authorVassallo-Bonner, Cen_US
dc.contributor.authorMoinuddin, SAen_US
dc.contributor.authorBirtle, Aen_US
dc.contributor.authorHoran, Gen_US
dc.contributor.authorRimmer, Yen_US
dc.contributor.authorVenkitaraman, Ren_US
dc.contributor.authorKhoo, Ven_US
dc.contributor.authorMitra, Aen_US
dc.contributor.authorHughes, Sen_US
dc.contributor.authorGibbs, Sen_US
dc.contributor.authorKapur, Gen_US
dc.contributor.authorBaker, Aen_US
dc.contributor.authorHansen, VNen_US
dc.contributor.authorPatel, Een_US
dc.contributor.authorHall, Een_US
dc.contributor.authorHYBRID Investigatorsen_US
dc.identifier.citationInternational journal of radiation oncology, biology, physics, 2020en_US
dc.description.abstract<h4>Purpose</h4>Hypofractionated radiation therapy can be used to treat patients with muscle-invasive bladder cancer unable to have radical therapy. Toxicity is a key concern, but adaptive plan-of the day (POD) image-guided radiation therapy delivery could improve outcomes by minimizing the volume of normal tissue irradiated. The HYBRID trial assessed the multicenter implementation, safety, and efficacy of this strategy.<h4>Methods</h4>HYBRID is a Phase II randomized trial that was conducted at 14 UK hospitals. Patients with T2-T4aN0M0 muscle-invasive bladder cancer unsuitable for radical therapy received 36 Gy in 6 weekly fractions, randomized (1:1) to standard planning (SP) or adaptive planning (AP) using a minimization algorithm. For AP, a pretreatment cone beam computed tomography (CT) was used to select the POD from 3 plans (small, medium, and large). Follow-up included standard cystoscopic, radiologic, and clinical assessments. The primary endpoint was nongenitourinary Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 (≥G3) toxicity within 3 months of radiation therapy. A noncomparative single stage design aimed to exclude ≥30% toxicity rate in each planning group in patients who received ≥1 fraction of radiation therapy. Local control at 3-months (both groups combined) was a key secondary endpoint.<h4>Results</h4>Between April 15, 2014, and August 10, 2016, 65 patients were enrolled (SP, n = 32; AP, n = 33). The median follow-up time was 38.8 months (interquartile range [IQR], 36.8-51.3). The median age was 85 years (IQR, 81-89); 68% of participants (44 of 65) were male; and 98% of participants had grade 3 urothelial cancer. In 63 evaluable participants, CTCAE ≥G3 nongenitourinary toxicity rates were 6% (2 of 33; 95% confidence interval [CI], 0.7%-20.2%) for the AP group and 13% (4 of 30; 95% CI, 3.8%-30.7%) for the SP group. Disease was present in 9/48 participants assessed at 3 months, giving a local control rate of 81.3% (95% CI, 67.4%-91.1%).<h4>Conclusions</h4>POD adaptive radiation therapy was successfully implemented across multiple centers. Weekly ultrahypofractionated 36 Gy/6 fraction radiation therapy is safe and provides good local control rates in this older patient population.en_US
dc.subjectHYBRID Investigatorsen_US
dc.titleClinical Outcomes of a Randomized Trial of Adaptive Plan-of-the-Day Treatment in Patients Receiving Ultra-hypofractionated Weekly Radiation Therapy for Bladder Cancer.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfInternational journal of radiation oncology, biology, physicsen_US
pubs.notesNot knownen_US
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.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.icrauthorHuddart, Roberten_US
dc.contributor.icrauthorHafeez, Shaistaen_US
dc.contributor.icrauthorLewis, Rebeccaen_US

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