Overview

This trial is active, not recruiting.

Conditions gastric cancer, bacterial infection due to helicobacter pylori (h. pylori)
Treatments placebo, lac triple therapy
Phase phase 3
Sponsor National Cancer Center, Korea
Start date November 2004
End date February 2018
Trial size 1810 participants
Trial identifier NCT01678027, NCCSTS04-103

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Placebo for LAC triple therapy
placebo
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
(Active Comparator)
PPI (Lansoprazole), Clarithromycin, Amoxicilline
lac triple therapy PPI-Clarithromycin containing triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.

Primary Outcomes

Measure
Gastric cancer incidence
time frame: 6 years after last participant enrollment

Secondary Outcomes

Measure
Gastric dysplasia incidence
time frame: 6 year after last participant enrollment
Gastric cancer incidence between Hp treatment and Hp uninfected groups
time frame: 6 year after last participant enrollment
Gastric cancer incidence according to final Hp status
time frame: 6 year after last participant enrollment
All-cause mortality
time frame: 6 year after last participant enrollment

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Additional Information

Official title Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
Principal investigator Il Ju Choi, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.