Condition category
Cancer
Date applied
09/09/2005
Date assigned
12/10/2005
Last edited
27/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof David Dearnaley

ORCID ID

Contact details

Royal Marsden NHS Trust
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00392535

Protocol/serial number

CCR2482

Study information

Scientific title

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

Acronym

CHHIP

Study hypothesis

To test the hypothesis that hypofractionated radiotherapy schedules for localised prostate cancer will improve the therapeutic ratio by either:
1. Improving tumour control.
2. Reducing normal tissue side effects.

Ethics approval

London MREC, 17/08/2004, ref: 04/MRE02/10

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Localised prostate cancer

Intervention

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 radiotherapy (IMRT) 57 Gy in 19 fractions over four weeks.
3. Hypofractionation group two: neoadjuvant hormone therapy and external beam radiotherapy (IMRT) 60 Gy in 20 fractions over four weeks.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Acute and late radiation induced side-effects

Secondary outcome measures

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

Overall trial start date

18/10/2002

Overall trial end date

17/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3170 (Added 12/09/2011: 3216 actually recruited)

Participant 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

Recruitment start date

18/10/2002

Recruitment end date

17/06/2011

Locations

Countries of recruitment

Ireland, New Zealand, Switzerland, United Kingdom

Trial participating centre

Royal Marsden NHS Trust
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk

Funders

Funder type

Research organisation

Funder name

CTAAC

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 preliminary safety results in: http://www.ncbi.nlm.nih.gov/pubmed/22169269
2012 prospective analysis study in: http://www.ncbi.nlm.nih.gov/pubmed/22169268
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26522334
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27339115

Publication citations

  1. Preliminary safety results

    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, Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial., Lancet Oncol., 2012, 13, 1, 43-54, doi: 10.1016/S1470-2045(11)70293-5.

  2. 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, Independent validation of genes and polymorphisms reported to be associated with radiation toxicity: a prospective analysis study., Lancet Oncol., 2012, 13, 1, 65-77, doi: 10.1016/S1470-2045(11)70302-3.

  3. Results

    Wilkins A, Mossop H, Syndikus I, Khoo V, Bloomfield D, Parker C, Logue J, Scrase C, Patterson H, Birtle A, Staffurth J, Malik Z, Panades M, Eswar C, Graham J, Russell M, Kirkbride P, O'Sullivan JM, Gao A, Cruickshank C, Griffin C, Dearnaley D, Hall E, 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., Lancet Oncol, 2015 , doi: 10.1016/S1470-2045(15)00280-6.

  4. Results

    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, Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial, Lancet Oncol, 2016 , doi: 10.1016/S1470-2045(16)30102-4.

Additional files

Editorial Notes

27/06/2016: publication reference added. 04/01/2011: the target number of participants was changed from 450 to 3170. 12/09/2011: the source of funding was changed from NCRI Southern Prostate Cancer Collaborative to CTAAC.