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ISRCTN
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ISRCTN78734883
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DOI
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10.1186/ISRCTN78734883
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ClinicalTrials.gov identifier
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NCT00002692
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EudraCT number
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Public title
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A randomised trial of intravenous versus intrahepatic arterial 5-Flurouracil (5-FU) and leucovorin for colorectal liver metastases
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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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CR05
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Study hypothesis
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To compare the efficacy and safety of intravenous and intrahepatic arterial infusion of 5-FU and leucovorin.
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Lay summary
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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 confirmed adenocarcinoma of the colon or rectum, confined to the liver, and not amenable to surgery or found to be unresectable during surgery
2. No previous treatment with 5-FU with the exception of adjuvant therapy (eg AXIS or QUASAR studies) completed more than 12 months prior to study entry
3. Adequate bone marrow function with platelets more than 100 x 10 to the power of 9 per litre; White Blood Count (WBC) more than 3.0 x 10 to the power of 9 per litre and neutrophils more than 1.5 x 10 to the power of 9 per litre at the time of study entry
4. No concurrent uncontrolled medical illness (eg uncontrolled heart failure, angina, infection, etc)
5. Life expectancy more than 3 months
6. WHO performance status 0, 1 or 2
7. Bilirubin less than 50 micromoles per litre
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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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16/12/1994
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Anticipated end date
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31/08/2000
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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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290
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Interventions
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Intrahepatic arterial infusion of 5-FU/leucovorin
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Primary outcome measure(s)
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Survival time
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Secondary outcome measure(s)
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Quality of life, objective tumour response, duration of response, toxicity.
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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 in http://www.ncbi.nlm.nih.gov/pubmed/12573372
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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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06/04/2000
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Last edited
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31/07/2009
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Date ISRCTN assigned
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06/04/2000
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