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ISRCTN
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ISRCTN73941125
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ClinicalTrials.gov identifier
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Public title
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A randomised trial comparing epirubicin, cisplatin and protracted venous infusion (PVI) 5-Fluorouracil (5FU) (ECF) to 5FU, Etoposide Leucovorin (FELU) in patients with inoperable or metastatic biliary cancer
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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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RMH E/C 1323
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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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Biliary Tract
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Participants - inclusion criteria
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1. Histological locally advanced or metastatic adenocarcinoma, squamous carcinoma or undifferentiated carcinoma of the gallbladder, intra/extra-hepatic bile ducts or Ampulla of Vater
2. Measurable disease on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or radiograph
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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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01/01/2000
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Anticipated end date
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31/12/2005
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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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1. FELU: 5FU 600 mg/m2 IV bolus 1-3 every 3 weeks Etoposide 120 mg/m2 IV infusion over 40 min days 1-3 every 3 weeks Leucovorin 60 mg/m2 IV bolus days 1-3 every 3 weeks
2. ECF: 5FU 200 mg/m2 daily continuous infusion for 24 weeks. Epirubicin 50 mg/m2 3-weekly IV bolus Cisplatin 60 mg/m2 3 weekly
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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
UKCCCR
Register Co-ordinator
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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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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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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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