Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma
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|ClinicalTrials.gov Identifier: NCT00201422|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|MALT Lymphoma||Other: Omeprazole, Amoxicillin, Clarithromycin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 1996|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
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
- 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. [ Time Frame: 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.
- objective regression rate and time to disease progression of primary low-grade gastric MALToma. [ Time Frame: 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).
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): NCT00201422
|National Taiwan University Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Li-Tzong Chen, MD,PhD||Taiwan cooperative oncology group|