Clinical Trial: Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Health Research Institutes, Taiwan

Current Primary Outcome: 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.


Original Primary Outcome: therapeutic effectiveness

Current Secondary Outcome: 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).


Original Secondary Outcome: objective regression rate and time to disease progression of primary low-grade gastric MALToma.

Information By: National Health Research Institutes, Taiwan

Dates:
Date Received: September 13, 2005
Date Started: June 1996
Date Completion:
Last Updated: March 25, 2016
Last Verified: March 2016