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ISRCTN
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ISRCTN21284267
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ClinicalTrials.gov identifier
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Public title
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A Pilot Randomised Trial Comparing Short Course Infusional 5-Fluourouracil with 5-Fluorouracil and Leucovorin as Adjuvant Therapy for Resected Colorectal Carcinoma
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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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SAFFA
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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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Colon, Rectum
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Participants - inclusion criteria
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1. Histologically verified adenocarcinoma of colon or rectum, Dukes stages B or C
2. No evidence of residual local disease or metastatic disease as assessed at time of operation, clinical examination, and by ultrasound scanning
3. No past history of malignancy apart from non melanotic carcinoma of the skin or in-situ carcinoma of the cervix
4. No previous chemotherapy
5. Normal bone marrow, renal and liver function
6. Patients must be randomised within 10 weeks of surgery
7. No medical contraindications to treatment
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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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19/08/1993
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Anticipated end date
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31/12/2006
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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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1. Regimen A: Continuous infusion of 5-fluorouracil over 12 weeks.
2. Regimen B: Folinic acid intravenous bolus injection, followed by 5-fluorouracil intravenous bolus injection given on 5 consecutive days and repeated every 28 days for six cycles
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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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Royal Marsden Hospital (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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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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The Royal Marsden NHS Foundation Trust (UK)
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Address
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Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Tel
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+44 (0)20 8661 3156
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Fax
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+44 (0)20 8643 9414
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Email
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Date applied
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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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