A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer

Conditions

Localised prostate cancer Cancer Prostate

Brand DH, Brüningk SC, Wilkins A, Fernandez K, Naismith O, Gao A, Syndikus I, Dearnaley DP, Tree AC, van As N, Hall E, Gulliford S, CHHiP Trial Management Group.

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10.1016/j.ijrobp.2020.12.041

Protocol for tumour-focused dose-escalated adaptive radiotherapy for the radical treatment of bladder cancer in a multicentre phase II randomised controlled trial (RAIDER): radiotherapy planning and delivery guidance

S. Hafeez, Amanda Webster, Vibeke N. Hansen, H. McNair, K. Warren-Oseni et al. (20 authors)

BMJ Open2020-12-0134 citations

10.1136/bmjopen-2020-041005

Linkage of the CHHiP randomised controlled trial with primary care data: a study investigating ways of supplementing cancer trials and improving evidence-based practice

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BMC Medical Research Methodology2020-07-256 citations

10.1186/s12874-020-01078-9

Derivation of dose/volume constraints for the anorectum from clinician-reported outcomes (CRO) in the CHHiP trial of radiotherapy (RT) fractionation.

Anna Wilkins, Olivia Naismith, Douglas Brand, Kathryn P. R. Fernandez, Emma Hall et al. (7 authors)

Journal of Clinical Oncology2018-02-201 citations

10.1200/jco.2018.36.6_suppl.87

Effect of dose to penile bulb (PB) on patient and clinician-reported erectile function (EF) in standard (SF) and hypofractionated (HF) prostate IGRT.

Julia Murray, Jamie Dean, Helen Mossop, Clare Griffin, Emma Hall et al. (7 authors)

Journal of Clinical Oncology2017-02-202 citations

10.1200/jco.2017.35.6_suppl.71

5-year patient-reported outcomes of bowel and urinary bother in the CHHiP trial (CRUK/06/016).

David P. Dearnaley, Helen Mossop, Isabel Syndikus, Vincent Khoo, D. Bloomfield et al. (20 authors)

Journal of Clinical Oncology2017-02-20

10.1200/jco.2017.35.6_suppl.23

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.

Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E, CHHiP Investigators.

2016-06-20916 citations

10.1016/s1470-2045(16)30102-4

Comparison of hypofractionated high-dose intensity-modulated radiotherapy schedules for prostate cancer: Results from the phase III randomized CHHiP trial (CRUK/06/016).

David P. Dearnaley, Isabel Syndikus, Helen Mossop, Alison Birtle, D. Bloomfield et al. (20 authors)

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Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.

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2015-10-2896 citations

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Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial.

Dearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, Gao A, Hassan S, Horwich A, Huddart R, Khoo V, Kirkbride P, Mayles H, Mayles P, Naismith O, Parker C, Patterson H, Russell M, Scrase C, South C, Staffurth J, Hall E.

2011-12-12217 citations

10.1016/s1470-2045(11)70293-5

Independent validation of genes and polymorphisms reported to be associated with radiation toxicity: a prospective analysis study.

Barnett GC, Coles CE, Elliott RM, Baynes C, Luccarini C, Conroy D, Wilkinson JS, Tyrer J, Misra V, Platte R, Gulliford SL, Sydes MR, Hall E, Bentzen SM, Dearnaley DP, Burnet NG, Pharoah PD, Dunning AM, West CM.

2011-12-12173 citations

10.1016/s1470-2045(11)70302-3

Interventions

1. Control group: neoadjuvant hormone therapy and external beam radiotherapy (IMRT) 74 Gy in 37 fractions over 7.5 weeks. 2. Hypofractionation group one: neoadjuvant hormone therapy and external beam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate 2. Clinical stage T1b ? T3a, N0, M0 (1997 TNM system) 3. Prostate Specific Antigen (PSA) less than 40 ng/ml 4. Estimated risk of lymph node metastases less than 30% 5. World Health Organisation (WHO) performance status zero or one 6. Normal blood count (Hb more than 11 g/dl, white blood cell count [WBC] more than 4000/mm^3, platelets more than 100,000/mm^3) 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Prior pelvic radiotherapy or radical prostatectomy 2. Previous androgen deprivation 3. Life expectancy less than ten years (less than five years for poorly differentiated cancers) 4. Previous active malignancy within the last five years other than basal cell carcinoma 5. Co-morbid conditions likely to impact on the advisability of radical radiotherapy (e.g. previously inflammatory bowel disease, previous colorectal surgery, significant bladder instability or urinary incontinence) 6. Full anticoagulation with e.g. Warfarin or Heparin 7. Hip prosthesis or fixation which would interfere with standard radiation beam configuration

Design outcomes

Primary

Measure	Time frame
Acute and late radiation induced side-effects	—

Secondary

Measure	Time frame
1. Freedom from prostate cancer recurrence 2. Development of metastases 3. Recommencement of hormonal treatment for disease occurrence 4. Cause specific and overall survival 5. Aspects of quality of life and health economics 6. Models of normal tissue and tumour control	—

Countries

England, Ireland, New Zealand, Switzerland, United Kingdom

Outcome results

None listed