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11 February 2012
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| [ Print-friendly version ] |
| A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer |
| ISRCTN | ISRCTN97182923 |
| ClinicalTrials.gov identifier | NCT00392535 |
| Public title | A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer |
| Scientific title | |
| Acronym | CHHIP |
| Serial number at source | CCR2482 |
| 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. As of 04/01/2011 target participant number increased from 450 to 3170 |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-trial-comparing-different-ways-of-giving-radiotherapy-for-prostate-cancer |
| Ethics approval | London MREC on 17/08/2004 (ref: 04/MRE02/10) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Ireland, New Zealand, Switzerland, United Kingdom |
| Disease/condition/study domain | Localised prostate cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 18/10/2002 |
| Anticipated end date | 17/06/2011 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 3170 (Added 12/09/2011: 3216 actually recruited) |
| 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 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. |
| Primary outcome measure(s) | Acute and late radiation induced side-effects. |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
Current source of funding as of 12/09/2011:
CTAAC Previous source of funding: NCRI Southern Prostate Cancer Collaborative |
| Trial website | |
| Publications | |
| Contact name | Prof David Dearnaley |
| Address | Royal Marsden NHS Trust |
| City/town | Sutton |
| Zip/Postcode | SM2 5PT |
| Country | United Kingdom |
| Sponsor | Institute of Cancer Research (UK) |
| Address | 123 Old Brompton Road |
| City/town | London |
| Zip/Postcode | SW7 3RP |
| Country | United Kingdom |
| Sponsor website: | http://www.icr.ac.uk |
| Date applied | 09/09/2005 |
| Last edited | 12/09/2011 |
| Date ISRCTN assigned | 12/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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