Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-Grade B Cell Lymphoma of MALToma.
Information source: National Health Research Institutes, Taiwan
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: MALT Lymphoma
Intervention: Omeprazole,Amoxicillin,Clarithromycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Health Research Institutes, Taiwan Official(s) and/or principal investigator(s):
Li-Tzong Chen, MD,PhD, Principal Investigator, Affiliation: Taiwan cooperative oncology group
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
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: therapeutic effectiveness
Secondary outcome: objective regression rate and time to disease progression of primary low-grade gastric MALToma.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 :
1. No enlargement of peripheral or mediastinal lymph node;
2. Peripheral blood smear revealing no leukemic or lymphomatous abnormalities;
3. Predominant of alimentary tract lesions with any adenopathy corresponding to
accepted lymphatic drainage route; and
4. 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 Criteria:
- 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.
Locations and Contacts
National Taiwan University Hospital, Taipei 112, Taiwan
Additional Information
Starting date: June 1996
Ending date: January 2004
Last updated: December 15, 2005
|
