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dc.contributor.authorDearnaley, D
dc.contributor.authorGriffin, CL
dc.contributor.authorLewis, R
dc.contributor.authorMayles, P
dc.contributor.authorMayles, H
dc.contributor.authorNaismith, OF
dc.contributor.authorHarris, V
dc.contributor.authorScrase, CD
dc.contributor.authorStaffurth, J
dc.contributor.authorSyndikus, I
dc.contributor.authorZarkar, A
dc.contributor.authorFord, DR
dc.contributor.authorRimmer, YL
dc.contributor.authorHoran, G
dc.contributor.authorKhoo, V
dc.contributor.authorFrew, J
dc.contributor.authorVenkitaraman, R
dc.contributor.authorHall, E
dc.date.accessioned2018-12-18T09:20:46Z
dc.date.issued2019-03
dc.identifier.citationInternational journal of radiation oncology, biology, physics, 2019, 103 (3), pp. 605 - 617
dc.identifier.issn0360-3016
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2980
dc.identifier.eissn1879-355X
dc.identifier.doi10.1016/j.ijrobp.2018.10.003
dc.description.abstractPurpose To establish the toxicity profile of high-dose pelvic lymph node intensity-modulated radiation therapy (IMRT) and to assess whether it is safely deliverable at multiple centers.Methods and materials In this phase 2 noncomparative multicenter trial, 124 patients with locally advanced, high-risk prostate cancer were randomized between prostate-only IMRT (PO) (74 Gy/37 fractions) and prostate and pelvic lymph node IMRT (P&P; 74 Gy/37 fractions to prostate, 60 Gy/37 fractions to pelvis). The primary endpoint was acute lower gastrointestinal (GI) Radiation Therapy Oncology Group (RTOG) toxicity at week 18, aiming to exclude a grade 2 or greater (G2+) toxicity-free rate of 80% in the P&P group. Key secondary endpoints included patient-reported outcomes and late toxicity.Results One hundred twenty-four participants were randomized (62 PO, 62 P&P) from May 2011 to March 2013. Median follow-up was 37.6 months (interquartile range [IQR], 35.4-38.9 months). Participants had a median age of 69 years (IQR, 64-74 years) and median diagnostic prostate-specific androgen level of 21.6 ng/mL (IQR, 11.8-35.1 ng/mL). At week 18, G2+ lower GI toxicity-free rates were 59 of 61 (96.7%; 90% confidence interval [CI], 90.0-99.4) for the PO group and 59 of 62 (95.2%; 90% CI, 88.0-98.7) for the P&P group. Patients in both groups reported similarly low Inflammatory Bowel Disease Questionnaire symptoms and Vaizey incontinence scores. The largest difference occurred at week 6 with 4 of 61 (7%) and 16 of 61 (26%) PO and P&P patients, respectively, experiencing G2+ toxicity. At 2 years, the cumulative proportion of RTOG G2+ GI toxicity was 16.9% (95% CI, 8.9%-30.9%) for the PO group and 24.0% (95% CI, 8.4%-57.9%) for the P&P group; in addition, RTOG G2+ bladder toxicity was 5.1% (95% CI, 1.7%-14.9%) for the PO group and 5.6% (95% CI, 1.8%-16.7%) for the P&P group.Conclusions PIVOTAL demonstrated that high-dose pelvic lymph node IMRT can be delivered at multiple centers with a modest side effect profile. Although safety data from the present study are encouraging, the impact of P&P IMRT on disease control remains to be established.
dc.formatPrint-Electronic
dc.format.extent605 - 617
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectPelvis
dc.subjectProstate
dc.subjectLymph Nodes
dc.subjectHumans
dc.subjectProstatic Neoplasms
dc.subjectLymphatic Metastasis
dc.subjectBiopsy
dc.subjectTreatment Outcome
dc.subjectLymphatic Irradiation
dc.subjectRadiotherapy Dosage
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectRadiotherapy, Intensity-Modulated
dc.subjectPatient Reported Outcome Measures
dc.titleToxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL).
dc.typeJournal Article
dcterms.dateAccepted2018-10-05
rioxxterms.versionofrecord10.1016/j.ijrobp.2018.10.003
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2019-03
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfInternational journal of radiation oncology, biology, physics
pubs.issue3
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/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Clinical Academic Radiotherapy (Dearnaley)
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/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Clinical Academic Radiotherapy (Dearnaley)
pubs.publication-statusPublished
pubs.volume103
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 (Dearnaley)en_US
dc.contributor.icrauthorDearnaley, Daviden
dc.contributor.icrauthorGriffin, Clareen
dc.contributor.icrauthorHall, Emmaen
dc.contributor.icrauthorLewis, Rebeccaen


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