NCT01002443

Brief Summary

Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial.The primary objective of this study is to evaluate whether Helicobacter pylori eradication improves glandular atrophy and intestinal metaplasia which are known to be precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

2.7 years

First QC Date

October 26, 2009

Last Update Submit

October 26, 2009

Conditions

Gastric Cancer

Keywords

Helicobacter pyloriglandular atrophyintestinal metaplasiasubtotal gastrectomygastric cancerPrecancerous lesion of gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Histological grading improvement rate

    6 years

Study Arms (2)

H. pylori eradication

ACTIVE COMPARATOR
Drug: Helicobacter pylori eradication

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Helicobacter pylori eradicationDRUG

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

H. pylori eradication
placeboDRUG

Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AGC or EGC confirmed by endoscopy
  • Histologically confirmed adenocarcinoma of stomach
  • Helicobacter pylori infection was confirmed by biopsy and CLO
  • Pre op CT stage: IA, IB, II, IIIA according to UICC TNM classification system
  • Pre op biopsy (body LC side) shows either intestinal metaplasia or glandular atrophy (at least grade 1)
  • Tumor location is suitable for subtotal gastrectomy- i.e. at or distal to lower body
  • Informed consent should be signed

You may not qualify if:

  • Recurrent gastric cancer
  • Previous serious side effect to antibiotics
  • H. pylori eradication treatment history
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute and Hospital, National Cancer Center

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

Location

Related Publications (1)

  • Cho SJ, Choi IJ, Kook MC, Yoon H, Park S, Kim CG, Lee JY, Lee JH, Ryu KW, Kim YW. Randomised clinical trial: the effects of Helicobacter pylori eradication on glandular atrophy and intestinal metaplasia after subtotal gastrectomy for gastric cancer. Aliment Pharmacol Ther. 2013 Sep;38(5):477-89. doi: 10.1111/apt.12402. Epub 2013 Jul 3.

    PMID: 23822578DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Il Ju Choi, M.D., Ph.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

July 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2009

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

KR(1)