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A randomised assessment of image guided radiotherapy within a phase 3 trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer

Murray, Julia, Griffin, Clare, Gulliford, Sarah, Syndikus, Isabel, Staffurth, John, Panades, Miguel, Scrase, Christopher, Parker, Chris, Khoo, Vincent, Dean, Jamie, Mayles, Helen, Mayles, Philip, Thomas, Simon, Naismith, Olivia, Baker, Angela, Mossop, Helen, Cruickshank, Clare, Hall, Emma and Dearnaley, David 2020. A randomised assessment of image guided radiotherapy within a phase 3 trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer. Radiotherapy and Oncology 142 , pp. 62-71. 10.1016/j.radonc.2019.10.017

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Abstract

Background and purpose Image-guided radiotherapy (IGRT) improves treatment set-up accuracy and provides the opportunity to reduce target volume margins. We introduced IGRT methods using standard (IGRT-S) or reduced (IGRT-R) margins in a randomised phase 2 substudy within CHHiP trial. We present a pre-planned analysis of the impact of IGRT on dosimetry and acute/late pelvic side effects using gastrointestinal and genitourinary clinician and patient-reported outcomes (PRO) and evaluate efficacy. Materials and methods CHHiP is a randomised phase 3, non-inferiority trial for men with localised prostate cancer. 3216 patients were randomly assigned to conventional (74 Gy in 2 Gy/fraction (f) daily) or moderate hypofractionation (60 or 57 Gy in 3 Gy/f daily) between October 2002 and June 2011. The IGRT substudy included a second randomisation assigning to no-IGRT, IGRT-S (standard CTV-PTV margins), or IGRT-R (reduced CTV-PTV margins). Primary substudy endpoint was late RTOG bowel and urinary toxicity at 2 years post-radiotherapy. Results Between June 2010 to July 2011, 293 men were recruited from 16 centres. Median follow-up is 56.9(IQR 54.3–60.9) months. Rectal and bladder dose-volume and surface percentages were significantly lower in IGRT-R compared to IGRT-S group; (p < 0.0001). Cumulative proportion with RTOG grade ≥ 2 toxicity reported to 2 years for bowel was 8.3(95% CI 3.2–20.7)%, 8.3(4.7–14.6)% and 5.8(2.6–12.4)% and for urinary 8.4(3.2–20.8)%, 4.6(2.1–9.9)% and 3.9(1.5–9.9)% in no IGRT, IGRT-S and IGRT-R groups respectively. In an exploratory analysis, treatment efficacy appeared similar in all three groups. Conclusion Introduction of IGRT was feasible in a national randomised trial and IGRT-R produced dosimetric benefits. Overall side effect profiles were acceptable in all groups but lowest with IGRT and reduced margins.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Elsevier
ISSN: 0167-8140
Date of First Compliant Deposit: 17 February 2020
Date of Acceptance: 25 October 2019
Last Modified: 18 Feb 2020 10:00
URI: http://orca.cf.ac.uk/id/eprint/129746

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