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ISRCTN
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ISRCTN47772397
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DOI
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10.1186/ISRCTN47772397
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
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Scientific title
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Acronym
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N/A
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Serial number at source
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RT01
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Study hypothesis
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To compare standard 64 Gy dose of conformal radiotherapy (CRT) with high dose 74 Gy CRT
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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1. Cancer of the prostate T1b-T3a, N0, M0
2. Prostate-Specific Antigen (PSA) less than 50 ng/ml
3. World Health Organisation (WHO) 0 or 1
4. No prior radiotherapy or prostatectomy
5. No previous androgen deprivation
6. No hip prosthesis or other condition precluding radiotherapy
7. Written informed consent
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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05/01/1998
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Anticipated end date
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31/12/2001
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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843
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Interventions
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1. Standard 64 Gy dose of conformal radiotherapy (CRT)
2. The other group receives high dose 74 Gy CRT
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Primary outcome measure(s)
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Local tumour control, incidence of biochemical failure, metastases, survival, side effects of radiation, quality of life and health economic resources
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15297138
2. 2004 questionnaire in http://www.ncbi.nlm.nih.gov/pubmed/15622611
3. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16828908
4. 2006 results on erectile dysfunction and radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/16949694
5. 2007 results on quality of life in http://www.ncbi.nlm.nih.gov/pubmed/17155990
6. 2007 results on early toxicity of escalated Vs standard dose conformal radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/17391791
7. 2007 results on escalated Vs standard dose conformal radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/17482880
8. 2009 results on dose-volume constraints to reduce rectal side effects in http://www.ncbi.nlm.nih.gov/pubmed/19540054
9. 2009 results on correlations between spatial distribution of the dose to the rectal wall and late rectal toxicity in http://www.ncbi.nlm.nih.gov/pubmed/19826203
10. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20443499
11. 2011 modellin late rectal toxicities results in http://www.ncbi.nlm.nih.gov/pubmed/21386140
12. 2011 additional rectal toxicity endpoint results in http://www.ncbi.nlm.nih.gov/pubmed/22119373
13. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21470834
14. 2012 prospective analysis study in http://www.ncbi.nlm.nih.gov/pubmed/22169268
15. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22520267
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Contact name
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Mr
Matthew
Sydes
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Address
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MRC Clinical Trials Unit
Cancer Division
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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25/04/2012
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Date ISRCTN assigned
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06/04/2000
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