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

NCT00327132 | Completed

• 1 other identifier: T3206
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 6

Brief Summary

1. 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. 2.The durability of complete histological remission after antibiotics
3. 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. 4.The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.
5. 5.The association between the CYP2C18/19 genetic polymorphisms and eradication of Hp infection after antibiotics.

Conditions

Gastric MALT Lymphoma

Keywords

Early-stage Lg/Hg Gastric MALT Lymphoma; Eradication of Helicobacter pylori (Hp)

Outcome Measures

Primary Outcomes (1)

• Hp eradication rate and complete histological rate

  10 years

Secondary Outcomes (1)

• overall survival (OS)Relapse-free survival (RFS)

  10 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: Omeprazole, Amoxicillin, Clarithromycin

Interventions

Omeprazole, Amoxicillin, Clarithromycin DRUG

Experimental Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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)
• 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.
• 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.
• Stage IE : lymphoma confined to the gastric wall without lymph node involvement.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Tri-Service General Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• Changhua Christian Hospital: collaborator
• Chi Mei Medical Hospital: collaborator

Study Sites (6)

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

National Taiwan University Hospital

Taipei, 112, Taiwan

Location

Tri-Services General Hospital

Taipei, 11490, Taiwan

Location

National Taiwan University Hospital

Taipei, 115, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Interventions

Omeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Jaw-Town, Lin, M.D., PHD

  Taiwan cooperative oncology group

  PRINCIPAL INVESTIGATOR

• Li Tzong Chen, M.D., Ph.D.

  Taiwan cooperative oncology group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

TW (6)