Status:
COMPLETED
Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
MALT Lymphoma
Eligibility:
All Genders
Phase:
NA
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
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 ...
Eligibility Criteria
Inclusion
- 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).
- The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson :
- No enlargement of peripheral or mediastinal lymph node;
- Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;
- Predominant of alimentary tract lesions with any adenopathy corresponding to accepted lymphatic drainage route; and
- No involvement of liver or spleen except by extension of contiguous disease .
- The monoclonality of B-cell must be confirmed by either immunohisto- chemistry (light-chain restriction) or molecular technique (IgH rearrangement).
- The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALToma.
- Patients must have evaluable disease by endoscopy and the nodal status by computed tomography. Endoscopic ultrasonography (EUS)\* is optional and for reference only.
- H. 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.
- 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.
- 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.
- 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.
- Stage IE : lymphoma confined to the gastric wall without lymph node involvement.
- 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.
- Stage IIE-1 : infiltration of adjacent lymph node.
- Patient must have signed the informed consent.
Exclusion
- Patients who have extensive gastrointestinal tract involvement are not eligible.
- Patients who have had previous history of extranodal lymphoma are not eligible.
- 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.
- Patients who had a history of allergic reaction to Amoxicillin and Erythromycin /Clarithromycin are not eligible.
- Patients whose cardiopulmonary status not allow him/her to have repeat endoscopy are not eligible.
- Patients who had prior surgery, chemo- or radiotherapy for their primary gastric lymphoma are not eligible.
- Patients who had previous anti-H. pylori therapy are not eligible.
Key Trial Info
Start Date :
June 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00201422
Start Date
June 1 1996
End Date
January 1 2004
Last Update
March 28 2016
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 112