Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
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| ClinicalTrials.gov Identifier: NCT00003151 |
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Recruitment Status :
Completed
First Posted : August 24, 2004
Last Update Posted : July 2, 2012
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RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.
PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Dietary Supplement: bismuth subcitrate Drug: amoxicillin Drug: clarithromycin Drug: metronidazole hydrochloride Drug: omeprazole Drug: tetracycline hydrochloride | Phase 2 |
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.
OUTLINE: 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.
PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 96 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma |
| Study Start Date : | September 1997 |
| Actual Primary Completion Date : | October 1998 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
PATIENT 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
PRIOR 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003151
| United Kingdom | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| University Birmingham N.H.S. Trust | |
| Birmingham, England, United Kingdom, B15 2TA | |
| Royal Free Hospital | |
| Hampstead, London, England, United Kingdom, NW3 2QG | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Royal Free Hospital School of Medicine | |
| London, England, United Kingdom, NW3 2PF | |
| Guy's, King's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| Hammersmith Hospital | |
| London, England, United Kingdom, W12 ONN | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1N 8AA | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 7LJ | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Royal Infirmary | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| Study Chair: | Patrice P. Carde, MD | Gustave Roussy, Cancer Campus, Grand Paris | |
| Study Chair: | John W. Sweetenham, MD | University of Colorado, Denver |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00003151 History of Changes |
| Other Study ID Numbers: |
EORTC-20961 EORTC-20961 CRC-EORTC-20961 HOVON-33 |
| First Posted: | August 24, 2004 Key Record Dates |
| Last Update Posted: | July 2, 2012 |
| Last Verified: | June 2012 |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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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 |
Additional relevant MeSH terms:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Amoxicillin Metronidazole Clarithromycin Tetracycline Bismuth tripotassium dicitrate Omeprazole Bismuth |
Anti-Bacterial Agents Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antacids |