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Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma

Phase 3
16 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma

OBJECTIVES: I. Determine the efficacy and response rate of triple antibiotic therapy for
Helicobacter pylori in the healing of lesions in patients with low grade gastric lymphoma.
II. Assess the efficacy of chlorambucil in the prevention of relapse in patients after
complete eradication of low grade gastric lymphoma. III. Determine the natural history of
unresected or partially resected low grade gastric lymphoma treated medically.

OUTLINE: This is a randomized study. Patients are randomized to receive chlorambucil or
placebo. Patients receive omeprazole daily for 1 week. Clarithromycin and tinidazole are
administered twice daily for 1 week for the eradication of H. pylori infection. Patients are
assessed every 2-3 months by endoscopy. Patients may receive a maximum of 3 courses of
treatment every 2-3 months. Other regimens may be used if full eradication of H. pylori is
not achieved. Patients who achieve complete response (eradication of H. pylori) are
randomized to receive oral chlorambucil or placebo daily for 14 days. Treatment is repeated
every 28 days for 6 courses. Patients are followed every 6 months for 2 years, then yearly

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or
completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori
infection No nodal metastases Microbiological evidence of current H. pylori infection
required No pathological evidence of enlarged abdominal lymph nodes by CT scan
Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Barry W. Hancock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital


United States: Federal Government

Study ID:




Start Date:

March 1995

Completion Date:

Related Keywords:

  • Gastric Cancer
  • stage I gastric cancer
  • Lymphoma
  • Stomach Neoplasms
  • Lymphoma, Non-Hodgkin