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

Alternate Title

Omeprazole and Amoxicillin and/or Vitamin and Mineral Supplements and/or Garlic Supplements in Preventing Stomach Cancer in Patients With Precancerous Stomach Lesions

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention	Closed	35 to 65	NCI	NCI-OH-95-C-N029 BICR-OH95-C-N029, NCT00134121

Objectives

Primary

1. Compare the effectiveness of omeprazole and amoxicillin and/or vitamin and mineral supplementation comprising vitamin E, ascorbic acid, and selenium and/or garlic supplementation, in terms of lowering the prevalence of severe chronic atrophic gastritis, intestinal metaplasia, dysplasia, and gastric cancer in patients with precancerous gastric lesions.

Secondary

1. Compare the effects of these regimens on the rates of transition among the precancerous histopathologic states in these patients.
2. Compare the rate of Helicobacter pylori (H. pylori) eradication and reinfection in patients treated with these regimens.
3. Compare the effect of these regimens on blood pressure in these patients.

Entry Criteria

Disease Characteristics:

• Gastroscopic results and histopathology must have been obtained through prior participation in an endoscopic survey conducted in Linqu County, Shandong Province, China



• Resident of Linqu County, Shandong Province, China, an area with high gastric cancer risk

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior treatment for Helicobacter pylori (H. pylori) infection
• No concurrent regular use of vitamin or mineral supplements

Patient Characteristics:

Age

• 35 to 65

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No history of bleeding disorder

Hepatic

• No liver disease

Renal

• No renal disease

Cardiovascular

• No heart failure

Pulmonary

• No emphysema

Other

• Not pregnant
• No allergy to penicillin or similar drugs
• No cancer except resected nonmelanoma skin cancer
• No other life-threatening illness

Expected Enrollment

Approximately 3,600 patients (approximately 2,400 randomized to arms I-VIII [patients with Helicobacter pylori (H. pylori) infection] and 1,000 randomized to arms IX-XII [patients without H. pylori infection]) will be accrued for this study.

Outline

This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to Helicobacter pylori (H. pylori) antibody status (positive vs negative) and gender. Patients with an initial H. pylori infection are randomized to 1 of 8 treatment arms (I-VIII). Patients testing negative for H. pylori are randomized to 1 of 4 treatment arms (IX-XII).

• Arm I: Patients receive oral omeprazole placebo and oral amoxicillin placebo twice daily for 2 weeks. Three months later, patients are re-evaluated for H. pylori infection. Patients with persistent H. pylori infection receive omeprazole placebo and amoxicillin placebo for an additional 2 weeks. Patients also receive oral vitamin and mineral supplement placebos comprising vitamin E placebo, ascorbic acid placebo, and selenium placebo twice daily and oral garlic supplement placebo twice daily beginning after completion of the initial 2-week treatment period with omeprazole and amoxicillin placebos and continuing for 88 months.



• Arm II: Patients receive omeprazole and amoxicillin placebos and vitamin and mineral supplement placebos as in arm I. Patients also receive an oral garlic supplement twice daily beginning after completion of the initial 2-week treatment period with omeprazole and amoxicillin placebos and continuing for 88 months.



• Arm III:Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also receive oral vitamin and mineral supplements comprising vitamin E, ascorbic acid, and selenium twice daily beginning after completion of the initial 2-week treatment period with omeprazole and amoxicillin placebos and continuing for 88 months and garlic supplement placebo as in arm I.



• Arm IV: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also receive vitamin and mineral supplements as in arm III and garlic supplement as in arm II.



• Arm V: Patients receive oral omeprazole and oral amoxicillin twice daily for 2 weeks. Three months later, patients are re-evaluated for H. pylori infection. Patients with persistent H. pylori infection receive omeprazole and amoxicillin for an additional 2 weeks. Patients also receive vitamin and mineral supplement placebos and garlic supplement placebo as in arm I.



• Arm VI: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive vitamin and mineral supplement placebos as in arm I and garlic supplement as in arm II.



• Arm VII: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive vitamin and mineral supplements as in arm III and garlic supplement placebo as in arm I.



• Arm VIII: Patients receive omeprazole and amoxicillin as in arm V. Patients also receive vitamin and mineral supplements as in arm III and garlic supplement as in arm II.



• Arm IX: Patients receive omeprazole and amoxicillin placebos, vitamin and mineral supplement placebos, and garlic supplement placebo as in arm I.



• Arm X: Patients receive omeprazole and amoxicillin placebos and vitamin and mineral supplement placebos as in arm I. Patients also receive garlic supplement as in arm II.



• Arm XI: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also receive vitamin and mineral supplements as in arm III and garlic supplement placebo as in arm I.



• Arm XII: Patients receive omeprazole and amoxicillin placebos as in arm I. Patients also receive vitamin and mineral supplements as in arm III and garlic supplement as in arm II.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Mitchel Gail, MD, PhD, Protocol chair		Ph: 301-496-4153

Registry Information
Official Title		A Randomized Multi-Intervention Trial to Inhibit Precancerous Lesions in Lindqu, Shandong Province
Registered in ClinicalTrials.gov		NCT00134121
Date Submitted to PDQ		2005-06-20
Information Last Verified		2007-07-10
NCI Grant/Contract Number		N01-CP40501