Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over EORTC-20961 CRC-EORTC-20961, HOVON-33, NCT00003151

Objectives

I.   Determine the rate of eradication of Helicobacter pylori using 
omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in 
patients with low grade gastric lymphoma.

II.  Determine the macroscopic/endoscopic and microscopic healing/remission 
rate after eradication of Helicobacter pylori in this patient population.

III. Determine the natural history of low grade gastric lymphoma after 
eradication of Helicobacter pylori.

Entry Criteria

Disease Characteristics:

Histologically proven, previously untreated, low grade gastric lymphoma
 Clinical stage I and II1
 No bulky disease
 No high grade component (grade 5 and 4, if monoclonality proven, allowed)

Documented presence/absence of H. pylori infection

Measurable and/or evaluable disease

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy to the abdomen

Surgery:
 No prior gastric surgery except simple closure of perforated ulcer with or    
  without wedge excision of the ulcer

Other:
 No prior therapy for gastric lymphoma
 At least 30 days since experimental therapy
 No other concurrent experimental therapy
 At least 30 days since antibiotics with activity against H. pylori

Patient Characteristics:

Age:
 18 and over  

Performance status:
 WHO 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 Not pregnant or lactating
 Fertile patients must use effective contraception
 No prior or concurrent malignancies unless:
  At least 1 year remission
  Low risk or recurrence
 No prior gastric malignancy
 No nonmalignant disease causing poor medical risk
 No allergy to omeprazole

Expected Enrollment

Approximately 60-96 patients will be accrued for this study.

Outline

This is a nonrandomized, open label, multicenter study.

Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and 
oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10.  
Patients are evaluated at 8 weeks.  Patients who experience complete remission 
and are H. pylori negative proceed to follow up.  Patients with complete 
remission or no change but who are H. pylori positive proceed to a second 
course of therapy with the previous schedule or with omeprazole bid, 
amoxicillin qid, and clarithromycin tid for 14 days.  Patients who experience 
no change but are H. pylori negative are followed at 6 and 9 months and 
restaged.

Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Patrice Carde, MD, Protocol chair		Ph: 33-1-4211-4321

Cancer Research UK Clinical Trials Unit at University of Glasgow

John Sweetenham, MD, Protocol chair(Contact information may not be current)		Ph: 720-848-0300; 800-473-2288

Registry Information
Official Title		A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma
Trial Start Date		1997-09-01
Registered in ClinicalTrials.gov		NCT00003151
Date Submitted to PDQ		1997-11-24
Information Last Verified		2000-05-01