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| ID | Type | Description | Link |
|---|---|---|---|
| BNLI-LY03 | |||
| EU-98040 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach.
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.
OBJECTIVES: I. Determine the efficacy and response rate of triple antibiotic therapy for Helicobacter pylori in the healing of lesions in patients with low grade gastric lymphoma. II. Assess the efficacy of chlorambucil in the prevention of relapse in patients after complete eradication of low grade gastric lymphoma. III. Determine the natural history of unresected or partially resected low grade gastric lymphoma treated medically.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorambucil | Drug | |||
| clarithromycin | Drug | |||
| omeprazole | Drug | |||
| tinidazole | Drug |
DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori infection No nodal metastases Microbiological evidence of current H. pylori infection required No pathological evidence of enlarged abdominal lymph nodes by CT scan Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal
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
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| Name | Affiliation | Role |
|---|---|---|
| Barry W. Hancock, MD | Cancer Research Centre at Weston Park Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| Oncology Centre Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19036078 | Result | 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. | |
| 11895791 |
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| Warsaw |
| 02 781 |
| Poland |
| Frere Hospital | Central Region | South Africa |
| Ospedale San Giovanni | Bellinzona | CH-6500 | Switzerland |
| Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England | HP21 8AL | United Kingdom |
| Bradford Hospitals NHS Trust | Bradford | England | BD9 6RJ | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | England | CT2 7NR | United Kingdom |
| Essex County Hospital | Colchester | England | United Kingdom |
| Walsgrave Hospital | Coventry | England | CV2 2DX | United Kingdom |
| Royal Free Hospital | Hampstead, London | England | NW3 2QG | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | England | IP4 5PD | United Kingdom |
| Leeds Teaching Hospital Trust | Leeds | England | LS1 3EX | United Kingdom |
| Charing Cross Hospital | London | England | W6 8RF | United Kingdom |
| Middlesex Hospital- Meyerstein Institute | London | England | WIT 3AA | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | L63 4JY | United Kingdom |
| Milton Keynes General Hospital | Milton Keynes | England | MK6 5LD | United Kingdom |
| Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Peterborough Hospitals Trust | Peterborough | England | PE3 6DA | United Kingdom |
| Salford Royal Hospitals NHS Trust | Salford | England | M6 8HD | United Kingdom |
| Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Good Hope Hospital Trust | West Midlands | England | B75 7RR | United Kingdom |
| Southend NHS Trust Hospital | Westcliff-on-Sea | England | United Kingdom |
| York District Hospital | York | England | Y031 8HE | United Kingdom |
| Kettering General Hosptial | Kettering, Northants | NNI6 8UZ | United Kingdom |
| James Paget Hospital | Norfolk | NR31 6LA | United Kingdom |
| Rotherham District General Hospital-NHS Trust | Rotherham | S60 2UD | United Kingdom |
| Salisbury District Hospital | Salisbury | SP2 8BJ | United Kingdom |
| Staffordshire General Hospital | Stafford | ST16 3SA | United Kingdom |
| Result |
| 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. |
| Result | 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002699 | Chlorambucil |
| D017291 | Clarithromycin |
| D009853 | Omeprazole |
| D014011 | Tinidazole |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
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