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ISRCTN
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ISRCTN28785842
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DOI
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10.1186/ISRCTN28785842
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ClinicalTrials.gov identifier
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NCT00003422
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EudraCT number
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Public title
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Pathology-guided treatment of rectal cancer
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Scientific title
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Pathology-guided treatment of rectal cancer: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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CR07
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Study hypothesis
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In inoperable rectal cancer: are local recurrence-free survival rates and quality of life optimised by giving all patients short course pre-operative radiotherapy, or is it a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?
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Lay summary
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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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Canada, United Kingdom
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Disease/condition/study domain
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Rectal cancer
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Participants - inclusion criteria
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1. Histologically confirmed adenocarcinoma of the rectum
2. Considered potentially operable
3. No evidence of metastases
4. Patient considered fit to receive either arm of the trial
5. No concurrent uncontrolled medical illness
6. No previous or current malignant disease likely to interfere with treatment or comparisons
7. Informed consent obtained
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/02/1998
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Anticipated end date
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05/08/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1350
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Interventions
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1. One group receives a short course pre-operative radiotherapy followed by surgery
2. The other group receives surgery followed by postoperative chemo-radiotherapy
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Primary outcome measure(s)
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Local recurrence (as defined using an algorithm designed for the trial).
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Secondary outcome measure(s)
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1. Local recurrence-free survival
2. Overall survival
3. Time to appearance of distant metastases
4. Disease-free survival
5. Morbidity
6. Quality of life
7. Economic implications
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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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http://www.ctu.mrc.ac.uk/studies/CR07.asp
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Publications
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2009 results in:
1. Initial results: http://www.ncbi.nlm.nih.gov/pubmed/19269519
2. Prospective study results: http://www.ncbi.nlm.nih.gov/pubmed/19269520
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Contact name
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Dr
David
Sebag-Montefiore
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Address
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Leeds Cancer Centre
Cookridge Hospital
Hospital Lane
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City/town
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Leeds
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Zip/Postcode
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LS16 6QB
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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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18/03/2009
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Date ISRCTN assigned
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06/04/2000
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