Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003151|
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : July 2, 2012
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|
|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|
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
|Study Chair:||Patrice P. Carde, MD||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||John W. Sweetenham, MD||University of Colorado, Denver|