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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 ORCID: https://orcid.org/0000-0002-7834-3172, 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: 04 May 2023 21:55
URI: https://orca.cardiff.ac.uk/id/eprint/129746

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