Prospective Study of First-Line Antibiotic Therapy for Early-Stage Gastric MALT Lymphoma for Treatment Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2006 by National Health Research Institutes, Taiwan
Sponsor:
Collaborators:
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:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00327132
First received: May 17, 2006
Last updated: September 14, 2006
Last verified: September 2006
  Purpose
  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: Allocation: Non-Randomized
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

Secondary Outcome Measures:
  • overall survival (OS)Relapse-free survival (RFS)

Estimated Enrollment: 90
Study Start Date: July 2006
Estimated Study Completion Date: December 2014
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327132

Contacts
Contact: Wei-lien Feng, RN,MSN 886-2-8792-3311 ext 17644 winnif@nhri.org.tw

Locations
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 80708
Contact: Wei Te-Chih, B.S    886-7-3121101 ext 6109    hemawei@nhri.org.tw   
Principal Investigator: Wen-Ming Wang         
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Ya-Lin WU, B.S.    886-4-22052121 ext 5372    yalin@nhri.org.tw   
Principal Investigator: Chang-Fang Chiu, M.D.         
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Contact: Mei-Wha Lee, B.S.    886-2-2543-3535 ext 3454    lmh@nhri.org.tw   
Principal Investigator: Chan-En Wang, M.D.         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 112
Contact: Bor-Rong Chen, B.S.    886-2-2312-3456 ext 7677    brong@nhri.org.tw   
Principal Investigator: Li-Tzong chen, M.D. PhD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 115
Contact: Ling-Fang Lin., B.S.    886-2-2312-3456 ext 7677    dale@nhri.org.tw   
Principal Investigator: Chi-An Chen, M.D.         
Tri-Services General Hospital Recruiting
Taipei, Taiwan, 11490
Principal Investigator: Tsai Yuan Shieh, M.D, Ph.D         
Veterans General Hospital-Taipei Recruiting
Taipei, Taiwan, 112
Contact: Hsueh-Pin Yu, B.S.    886-2-2871-2121 ext 2518    dhpyu@nhri.org.tw.   
Principal Investigator: Tzeng Shing Chen, M.D., PHD         
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

No publications provided

ClinicalTrials.gov Identifier: NCT00327132     History of Changes
Other Study ID Numbers: T3206
Study First Received: May 17, 2006
Last Updated: September 14, 2006
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
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014