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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Gastric MALT Lymphoma	Drug: Omeprazole, Amoxicillin, Clarithromycin	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	July 2006
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Experimental Arm	Drug: Omeprazole, Amoxicillin, Clarithromycin

Outcome Measures

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Primary Outcome Measures :

1. Hp eradication rate and complete histological rate [ Time Frame: 10 years ]

Secondary Outcome Measures :

1. overall survival (OS)Relapse-free survival (RFS) [ Time Frame: 10 years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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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Locations

Taiwan
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

Investigators

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:	NCT00327132 History of Changes
Other Study ID Numbers:	T3206
First Posted:	May 18, 2006
Last Update Posted:	March 25, 2016
Last Verified:	March 2016

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; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin; Stomach Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases	Gastrointestinal Diseases; Stomach Diseases; Anti-Bacterial Agents; Amoxicillin; Clarithromycin; Omeprazole; Anti-Infective Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protein Synthesis Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors