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A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma

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.

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.

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

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrice P. Carde, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

September 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • Lymphoma