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ISRCTN
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ISRCTN32414363
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DOI
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10.1186/ISRCTN32414363
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Adjuvant X-ray & 5-Fluorouracil (5-FU) Infusion Study
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Scientific title
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Acronym
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AXIS
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Serial number at source
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UK01 (AXIS)
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Study hypothesis
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To assess the efficacy and safety of peri-operative radiotherapy for rectal cancer and portal vein infusion of 5-fluorouracil in colon and rectal cancer
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Lay summary
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http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=95
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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. Suspected malignant carcinoma of rectum or colon
2. The patient must be fit for external radiation therapy (XRT) or 5-FU if allocated
3. The surgeon is uncertain whether adjuvant treatment is indicated
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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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01/11/1989
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Anticipated end date
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31/12/1997
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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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4000
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Interventions
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There are four treatment groups with all groups receiving surgery.
1. The first group receives peri-operative radiotherapy
2. The second group receives portal-vein infusion
3. The third group receives peri-operative radiotherapy plus portal-vein infusion
4. The fourth group receives surgery alone
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Primary outcome measure(s)
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Survival time; Local recurrence; Metastases
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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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2003 results on http://www.ncbi.nlm.nih.gov/pubmed/14515287
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Contact name
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Dr
Dionne
Cain
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Address
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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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Email
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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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28/02/2001
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Last edited
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12/04/2012
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Date ISRCTN assigned
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28/02/2001
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