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| Sponsor: | National Health Research Institutes, Taiwan |
|---|---|
| Collaborators: |
National Taiwan University Hospital Kaohsiung Medical University Kaohsiung Veterans General Hospital. Taipei Veterans General Hospital,Taiwan Mackay Memorial Hospital Taichung Veterans General Hospital National Cheng-Kung University Hospital |
| Information provided by: | National Health Research Institutes, Taiwan |
| ClinicalTrials.gov Identifier: | NCT00201422 |
Purpose
To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1 primary low-grade B cell lymphoma of MALT of the stomach
| Condition | Intervention | Phase |
|---|---|---|
|
MALT Lymphoma |
Drug: Omeprazole,Amoxicillin,Clarithromycin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-Grade B Cell Lymphoma of Mucosa-Associated Lymphoid Tissue Type of The Stomach |
| Estimated Enrollment: | 70 |
| Study Start Date: | June 1996 |
| Estimated Study Completion Date: | January 2004 |
To investigate the prevalence of H. pylori infection in patients with early stage of primary low-grade B cell lymphoma of MALT of the stomach in Taiwan.
-To evaluate the therapeutic effectiveness of H. pylori eradication in stage IE & IIE-1 primary low-grade B cell lymphoma of MALT of the stomach.
To evaluate the efficacy of Helicobacter pylori eradication therapy with respect to objective regression rate and time to disease progression of primary low-grade gastric MALToma.
To estimate any differences in therapeutic efficacy related to different stage of disease,eg. stage IE v.s. stage IIE-1.
To identify the causes of treatment failure, such as the stage of tumor, the presence of large cell component, and/or persistent, reactivation or reinfection of H. pylori etc.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan, 112 | |
| Principal Investigator: | Li-Tzong Chen, MD,PhD | Taiwan cooperative oncology group |
More Information
| Study ID Numbers: | T1296 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00201422 History of Changes |
| Health Authority: | Taiwan: Department of Health |
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MALT lymphoma diffuse large B-cell lymphoma, stomach Helicobacter pylori antibiotic therapy |
|
Anti-Infective Agents Amoxicillin Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Gastrointestinal Agents Omeprazole Enzyme Inhibitors Lymphoma, B-Cell, Marginal Zone Pharmacologic Actions |
Lymphoma, B-Cell Protein Synthesis Inhibitors Anti-Bacterial Agents Lymphatic Diseases Clarithromycin Neoplasms Therapeutic Uses Anti-Ulcer Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |