Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

NCT02407119 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: NCCCTS03-0621310280
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infection; Early Gastric Cancer; Endoscopic Resection

Keywords

H. pylori eradication; Atrophy; Intestinal metaplasia; Endoscopic resection; Stomach neoplasm

Outcome Measures

Primary Outcomes (2)

• Improvement (histological) of glandular atrophy

  Improvement of glandular atrophy at the corpus lesser curvature

  3 years after enrollment

• Incidence of metachronous gastric cancer

  Comparison of metachronous gastric cancer according to the allocated treatment

  3 years after last patient enrollment

Secondary Outcomes (2)

• Incidence of new gastric dysplasia

  3 years after last patient enrollment

• Overall survival

  3 years after last patient enrollment

Study Arms (2)

7 day H.pylori eradication

ACTIVE COMPARATOR

Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days

Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin

Placebo

PLACEBO COMPARATOR

Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days

Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin

Interventions

7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin DRUG

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.

Also known as: 7 day Proton pump inhibitor (PPI)-based standard triple therapy

7 day H.pylori eradication

Placebo, Omeprazole or Rabeprazole, Clarithromycin DRUG

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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

• Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423.

  PMID: 29562147 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Atrophy

Interventions

Rabeprazole; Clarithromycin; Amoxicillin; Proton Pump Inhibitors; Omeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Il Ju Choi, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: April 2, 2015
• Study Start: June 1, 2003
• Primary Completion: June 1, 2016
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

KR (1)