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ISRCTN
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ISRCTN93845533
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ClinicalTrials.gov identifier
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Public title
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A Randomised Trial of Infusional 5-Fluorouracil and Concomitant Radiotherapy in Locally Advanced Rectal Cancer, Comparing Three and Six Months of Infusional 5-Fluorouracil
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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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COLORAD
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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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Cancer of rectum
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Participants - inclusion criteria
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1. Histologically verified adenocarcinoma of the rectum, which is either:
a. Inoperable primary tumour
b. Locally recurrent tumour
c. Residual pelvic disease after resection as assessed either surgically or histopathologically
2. No evidence of metastatic disease
3. No past history of malignancy
4. No previous radiotherapy to the pelvis
5. Normal bone marrow, liver and renal function
6. No concurrent severe or life threatening illness
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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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01/01/1990
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Anticipated end date
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11/11/1994
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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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All patients receive continuous infusional 5-fluorouracil for 12 weeks plus radiotherapy to the pelvis, minimum 45 Gy given in twenty-five fractions over 5 weeks to start at the beginning of the 5th week of chemotherapy.
Depending upon the initial randomisation, patients receive either:
1. Group One: Continuous infusional 5-fluorouracil for a further 12 weeks.
2. Group Two: No further chemotherapy with 5-fluorouracil.
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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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Royal Marsden Hospital (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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Date applied
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19/08/2002
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Last edited
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29/05/2008
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Date ISRCTN assigned
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19/08/2002
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