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ISRCTN
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ISRCTN95638591
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ClinicalTrials.gov identifier
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Public title
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A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal 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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CR04
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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 confirmed adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy
2. Objectively assessable disease
3. No previous treatment with 5-fluorouracil or interferon
4. Adequate bone marrow function
5. No concurrent uncontrolled medical illness
6. Not on systemic corticosteroids at the time of study entry
7. Life expectancy of >3 months
8. World Health Organisation (WHO) performance status 0-2
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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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01/08/2000
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Anticipated end date
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01/08/2005
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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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Not provided at time of registration.
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Interventions
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Patients are randomised to one of two treatment arms:
1. Arm 5FU-LV: Chemotherapy with 5-fluorouracil and leucovorin repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease.
2. Arm 5LU-LV-IFN: Chemotherapy with 5-fluorouracil and leucovorin plus interferon-alpha repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease.
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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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Medical Research Council (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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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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19/08/2002
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Last edited
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10/09/2007
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Date ISRCTN assigned
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19/08/2002
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