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ISRCTN
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ISRCTN91411631
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ClinicalTrials.gov identifier
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Public title
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Post-Operative Radiotherapy for Selected High Risk Rectal Adenocarcinoma
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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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GI/HRR
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Study hypothesis
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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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Colorectal cancer
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Participants - inclusion criteria
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1. Histologically proven adenocarcinoma of the rectum
2. Surgery at or below pelvic brim
3. Curative operation, all macroscopic disease removed
4. Aged <80 years, 75 years if physically unfit
5. No previous history of multiple abdominal or pelvic surgical procedures
6. No evidence of small bowel descending into area of maximum dose of radiotherapy
7. Adequate bone marrow function
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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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01/01/2000
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Anticipated end date
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31/12/2005
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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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Not provided at time of registration
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Interventions
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Following surgery patients are randomised to one of two treatment arms:
1. Arm A: Post-operative radiotherapy, a midplane dose of 45 Gy given over 4 to 5 weeks
2. Arm B: No radiotherapy
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Primary outcome measure(s)
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Not provided at time of registration
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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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Northern and Yorkshire Clinical Trials and Research Unit (UK)
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Trial website
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Publications
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Contact name
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Dr
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-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Northern and Yorkshire Clinical Trials and Research Unit (UK)
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Address
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-
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City/town
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Leeds
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Zip/Postcode
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-
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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20/05/2008
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Date ISRCTN assigned
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19/08/2002
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