Overview

This trial is active, not recruiting.

Conditions helicobacter pylori infection, early gastric cancer, endoscopic resection
Treatments 7 day h.pylori eradication omeprazole or rabeprazole, clarithromycin, amoxicillin, placebo, omeprazole or rabeprazole, clarithromycin
Phase phase 3
Sponsor National Cancer Center, Korea
Start date June 2003
End date June 2016
Trial size 470 participants
Trial identifier NCT02407119, 1310280, NCCCTS03-062

Summary

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as new cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
7 day h.pylori eradication omeprazole or rabeprazole, clarithromycin, amoxicillin 7 day Proton pump inhibitor (PPI)-based standard triple therapy
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Clarithromycin 500 mg bid for 7 days, Amoxicillin 1,000 mg bid for 7 days.
(Placebo Comparator)
Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days
placebo, omeprazole or rabeprazole, clarithromycin Placebo
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Placebo for clarithromycin 500 mg bid for 7 days, Placebo for amoxicillin 1,000 mg bid for 7 days.

Primary Outcomes

Measure
Improvement (histological) of glandular atrophy and intestinal metaplasia lesions
time frame: 3 years after enrollment
Incidence of metachronous gastric cancer
time frame: 3 years after last patient enrollment

Secondary Outcomes

Measure
Incidence of new gastric dysplasia
time frame: 3 years after last patient enrollment
Overall survival
time frame: 3 years after last patient enrollment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Early Gastric cancer or high grade dysplasia confirmed by endoscopy - Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia - Submucosal invasion is not suspected - No evidence of ulceration or ulcer scar within the lesion - Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test - Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system - Informed consent should be signed Exclusion Criteria: - Recurrent gastric cancer - Previous serious side effect to antibiotics - H. pylori eradication treatment history - Poorly differentiated adenocarcinoma or Signet ring cell carcinoma - Undergoing operation due to complication of EMR - Undergoing operation due to remnant cancer - Other malignancy within the past 5 years - Pregnant or nursing women - Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases - Psychiatric disorder that would preclude compliance

Additional Information

Official title Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Principal investigator Il Ju Choi, MD, PhD
Description Helicobacter pylori is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.