Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY03
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Lymphoma (non-Hodgkins) cancer
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Cancer drug
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
18/05/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Non-resected, partially or completely resected low grade gastric lymphoma
2. Age 16 or over
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
18/05/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19036078
Publication citations
-
Results
Hancock BW, Qian W, Linch D, Delchier JC, Smith P, Jakupovic I, Burton C, Souhami R, Wotherspoon A, Copie-Bergman C, Capella C, Traulle C, Levy M, Cortelazzo S, Ferreri AJ, Ambrosetti A, Pinotti G, Martinelli G, Vitolo U, Cavalli F, Gisselbrecht C, Zucca E, Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial., Br. J. Haematol., 2009, 144, 3, 367-375, doi: 10.1111/j.1365-2141.2008.07486.x.