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ISRCTN
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ISRCTN84631770
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ClinicalTrials.gov identifier
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Public title
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A Randomised Trial Comparing the Efficacy of Intraperitoneal Drainage With or Without Intraperitoneal Cisplatin for Malignant Ascites in Gastrointestinal 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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IPCISPLATIN
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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 Duodenum, Stomach
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Participants - inclusion criteria
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1. Histologically verified locally advanced or metastatic adenocarcinoma of the gastrointestinal tract
2. Clinically confirmed symptomatic ascites
3. Glomerular filtrate rate of >40ml/min
4. Patients must not have received intraperitoneal cisplatin before
5. No concurrent intravenous cisplatin, and at least a 2 week gap after the completion of intravenous cisplatin before intraperitoneal therapy can be commenced
6. Intravenous chemotherapy (except cisplatin) may be given concurrently
7. No medical contraindications to treatment
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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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1. Group A: Intraperitoneal drainage only
2. Group B: Intraperitoneal drainage plus intraperitoneal cisplatin
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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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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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29/05/2008
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Date ISRCTN assigned
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19/08/2002
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