A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer
| ISRCTN | ISRCTN97182923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97182923 |
| ClinicalTrials.gov number | NCT00392535 |
| Secondary identifying numbers | CCR2482 |
- Submission date
- 09/09/2005
- Registration date
- 12/10/2005
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof David Dearnaley
Scientific
Scientific
Royal Marsden NHS Trust
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer |
| Study 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(s) | London MREC, 17/08/2004, ref: 04/MRE02/10 |
| 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 |
| Primary outcome measure | 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 study start date | 18/10/2002 |
| Overall study end date | 17/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3170 (Added 12/09/2011: 3216 actually recruited) |
| Total final enrolment | 3216 |
| 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 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
- England
- Ireland
- New Zealand
- Switzerland
- United Kingdom
Study participating centre
Royal Marsden NHS Trust
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Website | http://www.icr.ac.uk |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Research organisation
CTAAC
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Other publications | prospective analysis study | 01/01/2012 | Yes | No | |
| Results article | preliminary safety results | 01/01/2012 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No | |
| Results article | results | 01/08/2016 | Yes | No | |
| Protocol article | sub-study protocol | 16/02/2018 | Yes | No | |
| Results article | sub-study results | 01/01/2020 | 27/11/2019 | Yes | No |
| Results article | sub-study results | 01/12/2023 | 04/06/2024 | Yes | No |
Editorial Notes
04/06/2024: Publication reference added.
27/11/2019: Publication reference added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
25/06/2018: Publication reference added.
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.
