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ISRCTN
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ISRCTN43154562
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ClinicalTrials.gov identifier
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Public title
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Protocol for a randomised trial of triple anti-Heliocobacter therapy versus chlorambucil in an endoscopically diagnosed low grade gastric lymphoma
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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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LY03
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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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Lymphoma (non-Hodgkins) cancer
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Participants - inclusion criteria
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1. Non-resected, partially or completely resected low grade gastric lymphoma
2. Age 16 or over
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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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18/05/2001
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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. Regimen A: Colloidal bismuth 120 mg four times daily, metronidazole, 400 mg three times daily plus tetracycline 500 mg four times daily or amoxycillin 500 mg four times daily. In addition patients receive chlorambucil daily for 14 days, cycle to be repeated every 28 days for six cycles.
2. Regimen B: Colloidal bismuth 120 mg four times daily, metronidazole, 400 mg three times daily plus tetracycline 500 mg four times daily or amoxycillin 500 mg four times daily. No chlorambucil.
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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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Cancer Research 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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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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22/05/2008
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Date ISRCTN assigned
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01/07/2001
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