Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
NCT ID: NCT00003617
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
1995-03-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.
Detailed Description
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OUTLINE: This is a randomized study. Patients are randomized to receive chlorambucil or placebo. Patients receive omeprazole daily for 1 week. Clarithromycin and tinidazole are administered twice daily for 1 week for the eradication of H. pylori infection. Patients are assessed every 2-3 months by endoscopy. Patients may receive a maximum of 3 courses of treatment every 2-3 months. Other regimens may be used if full eradication of H. pylori is not achieved. Patients who achieve complete response (eradication of H. pylori) are randomized to receive oral chlorambucil or placebo daily for 14 days. Treatment is repeated every 28 days for 6 courses. Patients are followed every 6 months for 2 years, then yearly thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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chlorambucil
clarithromycin
omeprazole
tinidazole
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
16 Years
ALL
No
Sponsors
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Lymphoma Trials Office
OTHER
Principal Investigators
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Barry W. Hancock, MD
Role: STUDY_CHAIR
Cancer Research Centre at Weston Park Hospital
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Oncology Centre Institute
Warsaw, , Poland
Frere Hospital
Central Region, , South Africa
Ospedale San Giovanni
Bellinzona, , Switzerland
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Good Hope Hospital Trust
West Midlands, England, United Kingdom
Southend NHS Trust Hospital
Westcliff-on-Sea, England, United Kingdom
York District Hospital
York, England, United Kingdom
Kettering General Hosptial
Kettering, Northants, , United Kingdom
James Paget Hospital
Norfolk, , United Kingdom
Rotherham District General Hospital-NHS Trust
Rotherham, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Staffordshire General Hospital
Stafford, , United Kingdom
Countries
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References
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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 Feb;144(3):367-75. doi: 10.1111/j.1365-2141.2008.07486.x. Epub 2008 Nov 22.
Bertoni F, Conconi A, Capella C, Motta T, Giardini R, Ponzoni M, Pedrinis E, Novero D, Rinaldi P, Cazzaniga G, Biondi A, Wotherspoon A, Hancock BW, Smith P, Souhami R, Cotter FE, Cavalli F, Zucca E; International Extranodal Lymphoma Study Group; United Kingdom Lymphoma Group. Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 cooperative trial. Blood. 2002 Apr 1;99(7):2541-4. doi: 10.1182/blood.v99.7.2541.
Zucca E, Roggero E, Delchier J, et al.: Interim evaluation of gastric malt lymphoma response to antibiotics in the ongoing LY03 randomized cooperative trial of observation vs chlorambucil after anti-helicobacter therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A12, 2000.
Other Identifiers
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BNLI-LY03
Identifier Type: -
Identifier Source: secondary_id
EU-98040
Identifier Type: -
Identifier Source: secondary_id
CDR0000066695
Identifier Type: -
Identifier Source: org_study_id