dc.contributor.author | Dearnaley, D | |
dc.contributor.author | Griffin, CL | |
dc.contributor.author | Lewis, R | |
dc.contributor.author | Mayles, P | |
dc.contributor.author | Mayles, H | |
dc.contributor.author | Naismith, OF | |
dc.contributor.author | Harris, V | |
dc.contributor.author | Scrase, CD | |
dc.contributor.author | Staffurth, J | |
dc.contributor.author | Syndikus, I | |
dc.contributor.author | Zarkar, A | |
dc.contributor.author | Ford, DR | |
dc.contributor.author | Rimmer, YL | |
dc.contributor.author | Horan, G | |
dc.contributor.author | Khoo, V | |
dc.contributor.author | Frew, J | |
dc.contributor.author | Venkitaraman, R | |
dc.contributor.author | Hall, E | |
dc.date.accessioned | 2018-12-18T09:20:46Z | |
dc.date.issued | 2019-03-01 | |
dc.identifier.citation | International journal of radiation oncology, biology, physics, 2019, 103 (3), pp. 605 - 617 | |
dc.identifier.issn | 0360-3016 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2980 | |
dc.identifier.eissn | 1879-355X | |
dc.identifier.doi | 10.1016/j.ijrobp.2018.10.003 | |
dc.description.abstract | PURPOSE: 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.format | Print-Electronic | |
dc.format.extent | 605 - 617 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE INC | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Pelvis | |
dc.subject | Prostate | |
dc.subject | Lymph Nodes | |
dc.subject | Humans | |
dc.subject | Prostatic Neoplasms | |
dc.subject | Lymphatic Metastasis | |
dc.subject | Biopsy | |
dc.subject | Treatment Outcome | |
dc.subject | Lymphatic Irradiation | |
dc.subject | Radiotherapy Dosage | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Radiotherapy, Intensity-Modulated | |
dc.subject | Patient Reported Outcome Measures | |
dc.title | Toxicity 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.type | Journal Article | |
dcterms.dateAccepted | 2018-10-05 | |
rioxxterms.versionofrecord | 10.1016/j.ijrobp.2018.10.003 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-03 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | International journal of radiation oncology, biology, physics | |
pubs.issue | 3 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 103 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
icr.researchteam | ICR-CTSU Urology and Head and Neck Trials Team | |
icr.researchteam | Clinical Academic Radiotherapy (Dearnaley) | |
dc.contributor.icrauthor | Dearnaley, David | |
dc.contributor.icrauthor | Griffin, Clare | |
dc.contributor.icrauthor | Lewis, Rebecca | |
dc.contributor.icrauthor | Hall, Emma | |