Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT00003151
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C002791', 'term': 'bismuth tripotassium dicitrate'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D013752', 'term': 'Tetracycline'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-23', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['contiguous stage II marginal zone lymphoma', 'contiguous stage II small lymphocytic lymphoma', 'stage I marginal zone lymphoma', 'stage I small lymphocytic lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.\n\nPURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.', 'detailedDescription': 'OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission rate after eradication of Helicobacter pylori in this patient population. III. Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.\n\nOUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10. Patients are evaluated at 8 weeks. Patients who experience complete remission and are H. pylori negative proceed to follow up. Patients with complete remission or no change but who are H. pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven, previously untreated, low grade gastric lymphoma Clinical stage I and II1 No bulky disease No high grade component (grade 5 and 4, if monoclonality proven, allowed) Documented presence/absence of H. pylori infection Measurable and/or evaluable disease\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception No prior or concurrent malignancies unless: At least 1 year remission Low risk or recurrence No prior gastric malignancy No nonmalignant disease causing poor medical risk No allergy to omeprazole\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the abdomen Surgery: No prior gastric surgery except simple closure of perforated ulcer with or without wedge excision of the ulcer Other: No prior therapy for gastric lymphoma At least 30 days since experimental therapy No other concurrent experimental therapy At least 30 days since antibiotics with activity against H. pylori'}, 'identificationModule': {'nctId': 'NCT00003151', 'briefTitle': 'Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma', 'orgStudyIdInfo': {'id': 'EORTC-20961'}, 'secondaryIdInfos': [{'id': 'EORTC-20961'}, {'id': 'CRC-EORTC-20961'}, {'id': 'HOVON-33'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bismuth subcitrate', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'amoxicillin', 'type': 'DRUG'}, {'name': 'clarithromycin', 'type': 'DRUG'}, {'name': 'metronidazole hydrochloride', 'type': 'DRUG'}, {'name': 'omeprazole', 'type': 'DRUG'}, {'name': 'tetracycline hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA1 3NG', 'city': 'Bath', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal United Hospital', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'B15 2TA', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Birmingham N.H.S. Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'NW3 2QG', 'city': 'Hampstead, London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital'}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. James's Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2PF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital School of Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's, King's and St. Thomas' Hospitals Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 ONN', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1N 8AA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Middlesex Hospital- Meyerstein Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W6 8RF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology NHS Trust'}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': '0X3 7LJ', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SO14 0YG', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal South Hants Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'EH4 9NQ', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson Oncology Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Patrice P. Carde, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'John W. Sweetenham, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}