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Prospective Study of First-line Antibiotic Therapy for Early-stage Gastric MALT Lymphoma for Treatment Outcome

This study has been completed.
National Taiwan University Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
China Medical University Hospital
Changhua Christian Hospital
Chi Mei Medical Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan Identifier:
First received: May 17, 2006
Last updated: March 23, 2016
Last verified: March 2016
  1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma
  2. The durability of complete histological remission after antibiotics
  3. The usefulness of pattern of NF-kB and BCL-10 by IHC staining in prospectively predicting the Hp-dependence of gastric lg- and hg-MALT lymphoma
  4. The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.
  5. The association between the CYP2C18/19 genetic polymorphisms and eradication of Hp infection after antibiotics.

Condition Intervention
Gastric MALT Lymphoma
Drug: Omeprazole, Amoxicillin, Clarithromycin

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre,Prospective Study of First-line Antibiotic Therapy for Early-stage Low-grade and High-grade Gastric Mucosa-associated Lymphoid Tissue-type Lymphoma and Potential Predicting Factor for Treatment Outcome

Resource links provided by NLM:

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • Hp eradication rate and complete histological rate [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival (OS)Relapse-free survival (RFS) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: July 2006
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm Drug: Omeprazole, Amoxicillin, Clarithromycin

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients must have histologically confirmed primary gastric MALT lymphoma with or without clustering large cells (extranodal marginal zone lymphoma, and diffuse large cell lymphoma with features of MALT by REAL/WHO classification, Harris NL et al. 1994).

    • 1.1 The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson [38].

      • (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.
    • 1.2 The diagnosis of MALT lymphoma will be made by histopathologists from individual hospitals, in accordance with criteria defined by Isaacson et al. and Chang et al, and will be reviewed by the members of the TCOG Pathology Committee. This pathology review mechanism had been functioned well in the previous T1296 study (see J Natl Cancer Inst. 2005;97:1345-53)
    • 1.3 The patient must have no prior chemotherapy or radiotherapy for his/her gastric lg- or hg-MALToma.
  • Patients must have evaluable disease by endoscopy and/or the nodal status by computed tomography. Endoscopic ultrasonography (EUS) is mandatory to evaluate the depth of tumor infiltration and for status of perigastric lymph node enlargement.
  • Patients must have documented H. pylori infection before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.

    • 3.1 The following will be considered to have H. pylori infection: if any of above 4 tests show positive result.
  • 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.

    • 4.1 Stage IE : lymphoma confined to the gastric wall without lymph node involvement.
    • 4.2 Stage IIE : localized involvement of one or more GI site(s) on one side of the diaphragm with lymph node involvement, any depth of lymphoma infiltration into the gut wall. 4.21 Stage IIE-1: involvement of perigastric lymph node. 4.22 Stage IIE-2: abdominal, but beyond perigastric, lymph nodal involvement.
  • Patient must have signed the informed consent and agree to provide achieved pathologic material for immunohistochemical study and for RT-PCR t(11;18)(q21;q21) determination.

Exclusion Criteria:

  • Patients with extensive gastrointestinal tract involvement are not eligible.
  • Patients with previous history of extranodal lymphoma are not eligible.
  • Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node, e.g. paraaortic, renal hilar, retroperitoneal, mesenteric, or lymph node of gastrosplenic ligament and of hepatoduodenal ligament; or involvement of lymph node above and below diaphragm (Stage III) or other visceral organ involvement (stage IV) are not eligible.
  • Patients with cardiopulmonary status that do not allow repeat endoscopy are not eligible.
  • Patients with prior antibiotics, chemo- or radiotherapy for their gastric lymphoma are not eligible.
  • Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study are not eligible.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00327132

Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80708
China Medical University Hospital
Taichung, Taiwan, 40447
Mackay Memorial Hospital
Taipei, Taiwan, 104
National Taiwan University Hospital
Taipei, Taiwan, 112
Tri-Services General Hospital
Taipei, Taiwan, 11490
National Taiwan University Hospital
Taipei, Taiwan, 115
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
China Medical University Hospital
Changhua Christian Hospital
Chi Mei Medical Hospital
Principal Investigator: Jaw-Town , Lin, M.D., PHD Taiwan cooperative oncology group
Principal Investigator: Li Tzong Chen, M.D., Ph.D. Taiwan cooperative oncology group
  More Information

Responsible Party: National Health Research Institutes, Taiwan Identifier: NCT00327132     History of Changes
Other Study ID Numbers: T3206 
Study First Received: May 17, 2006
Last Updated: March 23, 2016
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Early-stage Lg/Hg Gastric MALT Lymphoma
Eradication of Helicobacter pylori (Hp)

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on October 26, 2016