Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
05/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Matthew Sydes

ORCID ID

Contact details

MRC Clinical Trials Unit
Cancer Division
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RT01

Study information

Scientific title

Acronym

Study hypothesis

To compare standard 64 Gy dose of conformal radiotherapy (CRT) with high dose 74 Gy CRT

Ethics approval

Not provided at time of registration

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

Cancer

Intervention

1. Standard 64 Gy dose of conformal radiotherapy (CRT)
2. The other group receives high dose 74 Gy CRT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Local tumour control, incidence of biochemical failure, metastases, survival, side effects of radiation, quality of life and health economic resources

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/01/1998

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Other

Gender

Male

Target number of participants

843

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/01/1998

Recruitment end date

31/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

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
16. 2014 long-term results in http://www.ncbi.nlm.nih.gov/pubmed/24581940

Publication citations

  1. Results on escalated Vs standard dose conformal radiotherapy

    Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK, , Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial., Lancet Oncol., 2007, 8, 6, 475-487, doi: 10.1016/S1470-2045(07)70143-2.

  2. Results on correlations between spatial distribution of the dose to the rectal wall and late rectal toxicity

    Buettner F, Gulliford SL, Webb S, Sydes MR, Dearnaley DP, Partridge M, Assessing correlations between the spatial distribution of the dose to the rectal wall and late rectal toxicity after prostate radiotherapy: an analysis of data from the MRC RT01 trial (ISRCTN 47772397)., Phys Med Biol, 2009, 54, 21, 6535-6548, doi: 10.1088/0031-9155/54/21/006.

  3. Results

    Buettner F, Gulliford SL, Webb S, Partridge M, Using Bayesian logistic regression to evaluate a new type of dosimetric constraint for prostate radiotherapy treatment planning., Med Phys, 2010, 37, 4, 1768-1777.

  4. Modellin late rectal toxicities results

    Buettner F, Gulliford SL, Webb S, Partridge M, Modeling late rectal toxicities based on a parameterized representation of the 3D dose distribution., Phys Med Biol, 2011, 56, 7, 2103-2118, doi: 10.1088/0031-9155/56/7/013.

  5. Additional rectal toxicity endpoint results

    Gulliford SL, Partridge M, Sydes MR, Webb S, Evans PM, Dearnaley DP, Parameters for the Lyman Kutcher Burman (LKB) model of Normal Tissue Complication Probability (NTCP) for specific rectal complications observed in clinical practise., Radiother Oncol, 2012, 102, 3, 347-351, doi: 10.1016/j.radonc.2011.10.022.

  6. 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.

  7. Results

    Buettner F, Gulliford SL, Webb S, Sydes MR, Dearnaley DP, Partridge M, The dose-response of the anal sphincter region--an analysis of data from the MRC RT01 trial., Radiother Oncol, 2012, 103, 3, 347-352, doi: 10.1016/j.radonc.2012.03.002.

  8. Sydes MR, Stephens RJ, Moore AR, Aird EG, Bidmead AM, Fallowfield LJ, Graham J, Griffiths S, Mayles WP, McGuire A, Stanley S, Warrington AP, Dearnaley DP, , Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer., Radiother Oncol, 2004, 72, 2, 199-211, doi: 10.1016/j.radonc.2004.04.007.

  9. Mayles WP, Moore AR, Aird EG, Bidmead AM, Dearnaley DP, Griffiths SE, Warrington AP, , Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397)., Radiother Oncol, 2004, 73, 2, 199-207.

  10. Moore AR, Warrington AP, Aird EG, Bidmead AM, Dearnaley DP, A versatile phantom for quality assurance in the UK Medical Research Council (MRC) RT01 trial (ISRCTN47772397) in conformal radiotherapy for prostate cancer., Radiother Oncol, 2006, 80, 1, 82-85, doi: 10.1016/j.radonc.2006.06.003.

  11. Mangar SA, Sydes MR, Tucker HL, Coffey J, Sohaib SA, Gianolini S, Webb S, Khoo VS, , Dearnaley DP, Evaluating the relationship between erectile dysfunction and dose received by the penile bulb: using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397)., Radiother Oncol, 2006, 80, 3, 355-362, doi: 10.1016/j.radonc.2006.07.037.

  12. Stephens RJ, Dearnaley DP, Cowan R, Sydes M, Naylor S, Fallowfield L, , The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397)., BJU Int., 2007, 99, 2, 301-310, doi: 10.1111/j.1464-410X.2006.06560.x.

  13. Dearnaley DP, Sydes MR, Langley RE, Graham JD, Huddart RA, Syndikus I, Matthews JH, Scrase CD, Jose CC, Logue J, Stephens RJ, , The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397)., Radiother Oncol, 2007, 83, 1, 31-41, doi: 10.1016/j.radonc.2007.02.014.

  14. Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sánchez-Nieto B, Partridge M, Sydes MR, Webb S, Dearnaley DP, Dose-volume constraints to reduce rectal side effects from prostate radiotherapy: evidence from MRC RT01 Trial ISRCTN 47772397., Int. J. Radiat. Oncol. Biol. Phys., 2010, 76, 3, 747-754, doi: 10.1016/j.ijrobp.2009.02.025.

  15. Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP, The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397)., Clin Oncol (R Coll Radiol), 2011, 23, 9, 613-624, doi: 10.1016/j.clon.2011.03.001.

  16. Dearnaley DP, Jovic G, Syndikus I, Khoo V, Cowan RA, Graham JD, Aird EG, Bottomley D, Huddart RA, Jose CC, Matthews JH, Millar JL, Murphy C, Russell JM, Scrase CD, Parmar MK, Sydes MR, Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial., Lancet Oncol., 2014, 15, 4, 464-473, doi: 10.1016/S1470-2045(14)70040-3.

Additional files

Editorial Notes