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dc.contributor.authorHuddart, R
dc.contributor.authorHafeez, S
dc.contributor.authorLewis, R
dc.contributor.authorMcNair, H
dc.contributor.authorSyndikus, I
dc.contributor.authorHenry, A
dc.contributor.authorStaffurth, J
dc.contributor.authorDewan, M
dc.contributor.authorVassallo-Bonner, C
dc.contributor.authorMoinuddin, SA
dc.contributor.authorBirtle, A
dc.contributor.authorHoran, G
dc.contributor.authorRimmer, Y
dc.contributor.authorVenkitaraman, R
dc.contributor.authorKhoo, V
dc.contributor.authorMitra, A
dc.contributor.authorHughes, S
dc.contributor.authorGibbs, S
dc.contributor.authorKapur, G
dc.contributor.authorBaker, A
dc.contributor.authorHansen, VN
dc.contributor.authorPatel, E
dc.contributor.authorHall, E
dc.contributor.authorHYBRID Investigators
dc.date.accessioned2020-12-17T15:53:29Z
dc.date.issued2020-12-11
dc.identifier.citationInternational journal of radiation oncology, biology, physics, 2020
dc.identifier.issn0360-3016
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4257
dc.identifier.eissn1879-355X
dc.identifier.doi10.1016/j.ijrobp.2020.11.068
dc.description.abstractPurpose 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.Methods 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.Results 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%).Conclusions 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.
dc.formatPrint-Electronic
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHYBRID Investigators
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.
dc.typeJournal Article
dcterms.dateAccepted2020-11-25
rioxxterms.versionofrecord10.1016/j.ijrobp.2020.11.068
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2020-12-11
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfInternational journal of radiation oncology, biology, physics
pubs.notesNot known
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.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-statusPublished
pubs.embargo.termsNot known
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
dc.contributor.icrauthorHuddart, Roberten
dc.contributor.icrauthorHafeez, Shaistaen
dc.contributor.icrauthorLewis, Rebeccaen


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