Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Omeprazole, Amoxicillin, Clarithromycin Anti-H. pylori Therapy (Triple therapy) |
Other: Omeprazole, Amoxicillin, Clarithromycin
Omeprazole20 mg,Clarithromycin500 mg b.i.d.,Day 1-14 plus Amoxicillin 500 mg q.i.d.,Day 1-14 plus
|
Outcome Measures
Primary Outcome Measures
- 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. [Four weeks after the completion of anti-H. pylori therapy by CT scan]
Four weeks after the completion of anti-H. pylori therapy, patients shall have repeat endoscopy and abdominal CT to evaluate the H.pylori status and the response of MALToma.
Secondary Outcome Measures
- objective regression rate and time to disease progression of primary low-grade gastric MALToma. [3-6 months by EUS]
atients who achieve complete or persistent partial response will receive no further treatment and have regular follow-up as section till tumor progression (relapse).
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patients must have histologically confirmed primary low-grade B-cell lymphoma of MALT of the stomach which including the following types : diffuse small lymphocytic, diffuse small cleaved, and some diffuse mixed small and large cell types by Working Formulation (Harris NL et al. 1994)(20).
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The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :
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No enlargement of peripheral or mediastinal lymph node;
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Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;
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Predominant of alimentary tract lesions with any adenopathy corresponding to accepted lymphatic drainage route; and
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No involvement of liver or spleen except by extension of contiguous disease .
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The monoclonality of B-cell must be confirmed by either immunohisto- chemistry (light-chain restriction) or molecular technique (IgH rearrangement).
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The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALToma.
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Patients must have evaluable disease by endoscopy and the nodal status by computed tomography. Endoscopic ultrasonography (EUS)* is optional and for reference only.
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- pylori infection will be evaluated by the following tests: histology, rapid urease test (CLO-test), and serology C13-urea breath test (UBT) and bacterial culture* are optional and for reference only.
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The following will be considered to have H. pylori infection : at least two of the following 3 tests show positive results, rapid urease test (CLO-test), histology and serology.
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For C13-urea breath test, rapid urease test and histology to examine H. pylori, the examination must be performed at least 4 weeks apart from the latest antibiotics or non-steroid anti-inflammatory drug ingestion.
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Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Abor staging system modified by Musshoff for primary extranodal lymphoma.
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Stage IE : lymphoma confined to the gastric wall without lymph node involvement.
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Stage IIE : localized involvement of one or more GI site(s) on one side of the diaphragm with lymph node infiltration, any depth of lymphoma infiltration into the gut wall.
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Stage IIE-1 : infiltration of adjacent lymph node.
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Patient must have signed the informed consent.
Exclusion Criteria:
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Patients who have extensive gastrointestinal tract involvement are not eligible.
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Patients who have had previous history of extranodal lymphoma are not eligible.
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Patients who have disease beyond stage IIE-2: infiltration of regional lymph node, e.g. paraaortic, renal hilar, retroperitoneal, mesenteric, or lymph node of gastrosplenic ligment and of hepatoduodenal ligment are not eligible.
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Patients who had a history of allergic reaction to Amoxicillin and Erythromycin /Clarithromycin are not eligible.
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Patients whose cardiopulmonary status not allow him/her to have repeat endoscopy are not eligible.
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Patients who had prior surgery, chemo- or radiotherapy for their primary gastric lymphoma are not eligible.
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Patients who had previous anti-H. pylori therapy are not eligible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 112 |
Sponsors and Collaborators
- National Health Research Institutes, Taiwan
Investigators
- Principal Investigator: Li-Tzong Chen, MD,PhD, Taiwan cooperative oncology group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- T1296