A randomised assessment of image guided radiotherapy within a phase 3 trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer.
Date
2020-01-01Author
Murray, J
Griffin, C
Gulliford, S
Syndikus, I
Staffurth, J
Panades, M
Scrase, C
Parker, C
Khoo, V
Dean, J
Mayles, H
Mayles, P
Thomas, S
Naismith, O
Baker, A
Mossop, H
Cruickshank, C
Hall, E
Dearnaley, D
CHHiP Investigators,
Type
Journal Article
Metadata
Show full item recordAbstract
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. ISRCTN: 97182923.
Subject
CHHiP Investigators
Rectum
Humans
Prostatic Neoplasms
Neoplasm Staging
Radiotherapy Planning, Computer-Assisted
Aged
Aged, 80 and over
Middle Aged
Male
Radiotherapy, Intensity-Modulated
Fiducial Markers
Radiotherapy, Image-Guided
Patient Reported Outcome Measures
Radiation Dose Hypofractionation
Research team
Clinical Trials & Statistics Unit
ICR-CTSU Urology and Head and Neck Trials Team
Clinical Academic Radiotherapy (Dearnaley)
Radiotherapy Physics Modelling
Language
eng
Date accepted
2019-10-25
License start date
2020-01
Citation
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2020, 142 pp. 62 - 71
Publisher
ELSEVIER IRELAND LTD
Except where otherwise noted, this item's license is described
as
https://creativecommons.org/licenses/by/4.0
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