Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00003151
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Royal Free Hospital
🇬🇧Hampstead, London, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Royal Free Hospital School of Medicine
🇬🇧London, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
University Birmingham N.H.S. Trust
🇬🇧Birmingham, England, United Kingdom
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
St. James's Hospital
🇬🇧Leeds, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom