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

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
thereafter.

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