Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication

Phase 3Active Not RecruitingNCT01678027

National Cancer Center, Korea1,838 enrolled

Overview

This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.

Helicobacter pylori infection is associated with gastric cancer in epidemiological studies. However, it is still unknown whether H. pylori eradication is useful and required to prevent gastric cancer. Gastric cancer risk is increased in family members of gastric cancer patient. Though there is no direct evidence that H. pylori infection is a risk factor for gastric cancer in family members of gastric cancer, current European guideline recommends H. pylori eradication in first-degree relatives of gastric cancer patients. In this study, the investigators will evaluate whether H. pylori eradication can reduce gastric cancer risk in the first-degree family members of gastric cancer patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,838

Conditions

Gastric Cancer Helicobacter Pylori Infection Family Members

Interventions

PlaceboDRUG

Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.

LAC triple therapyDRUG

Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy * Informed consent should be signed Exclusion Criteria: * Gastric cancer history * Other malignancy within the past 5 years * Hereditary cancer family member (HNPCC, FAP) * Peptic ulcer history * Peptic ulcer, esophageal cancer, gastric cancer case found at EGD * H. pylori eradication treatment history * Previous serious side effect to antibiotics * Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases * Pregnant or nursing women * Psychiatric disorder that would preclude compliance, alcoholics * Refuse informed consent

Locations (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Gastric cancer incidence

The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status. Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.

Time frame: 6 years after last participant enrollment

Secondary Outcomes

Gastric dysplasia incidence

Incidence of gastric dysplasia according to the H. pylori treatment

Time frame: 6 year after last participant enrollment

Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups

Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group

Time frame: 6 year after last participant enrollment

Gastric cancer incidence according to H. pylori status

Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group

Time frame: 6 year after last participant enrollment

All-cause mortality

All-cause mortality between H. pylori treatment group and placebo group

Time frame: 6 year after last participant enrollment

Data from ClinicalTrials.gov

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