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ISRCTN
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ISRCTN43866427
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ClinicalTrials.gov identifier
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Public title
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A Randomised study of continuous Infusional 5-Fluorouracil (5FU) with or without bolus Mitomycin-C in patients with advanced oesophago-gastric 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 1040
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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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Oesophagus, Stomach
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Participants - inclusion criteria
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1. Histological evidence of metastatic carcinoma of the oesophagus or stomach
2. Histological evidence of locally advanced oesophageal or gastric carcinoma, not amenable to surgery or radiotherapy and for whom high dose chemotherapy or more intensive chemotherapy is not appropriate, normally around the age of 60
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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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01/01/1996
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Anticipated end date
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31/03/2001
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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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Two Arms:
1. Portal Vein Infusion (PVI) 5FU 300 mg/m2/day over 24 weeks
2. PVI 5FU 300 mg/m2/day over 24 weeks + Mitomycin-c 7 mg/m2 (total dose no more than 56 mg) four courses over 24 weeks
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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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22/05/2008
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Date ISRCTN assigned
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19/08/2002
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