Helicobacter Pylori InfectionPhase 3NCT02407119
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD
A Phase 3 study testing 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin in people with Helicobacter Pylori Infection and Early Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection, Early Gastric Cancer, Endoscopic Resection
- What is being tested?
- 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2003to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
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.
Read the detailed 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 and prevents metachronous gastric cancer 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.
- Being tested
- 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin, Placebo, Omeprazole or Rabeprazole, Clarithromycin
- Keywords
- H. pylori eradication, Atrophy, Intestinal metaplasia, Endoscopic resection, Stomach neoplasm
- Medical subject headings
- Stomach Neoplasms, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, AmoxicillinDrug
Also called 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, Omeprazole or Rabeprazole, ClarithromycinDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement (histological) of glandular atrophy
Improvement of glandular atrophy at the corpus lesser curvature
Measured: 3 years after enrollment
Incidence of metachronous gastric cancer
Comparison of metachronous gastric cancer according to the allocated treatment
Measured: 3 years after last patient enrollment
Secondary outcomes (2)
Incidence of new gastric dysplasia
Comparison of new gastric dysplasia according to the allocated treatment
Measured: 3 years after last patient enrollment
Overall survival
Comparison of overall survival according to the allocated treatment
Measured: 3 years after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJun 2003
- Primary completionJun 2016
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Il Ju Choi, National Cancer Center, Korea
- Investigators
- Il Ju Choi, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407119
- Sponsor's protocol ID
- NCCCTS03-062
- Other IDs
- 1310280
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2015
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29562147
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02407119
- Acronym / sponsor ID
- NCCCTS03-062
- Keywords
- H. pylori eradication, Atrophy, Intestinal metaplasia, Endoscopic resection, Stomach neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 470 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2003 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 and prevents metachronous gastric cancer 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 day H.pylori eradication | Active comparator | Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, AmoxicillinTreatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days |
| Placebo | Placebo comparator | Drug: Placebo, Omeprazole or Rabeprazole, ClarithromycinOmeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Early Gastric cancer or high grade dysplasia confirmed by endoscopy
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, AmoxicillinAlso: 7 day Proton pump inhibitor (PPI)-based standard triple therapyOmeprazole 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. | Drug | 7 day H.pylori eradication |
| Placebo, Omeprazole or Rabeprazole, ClarithromycinAlso: PlaceboOmeprazole 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. | Drug | Placebo |
Primary outcome
Improvement (histological) of glandular atrophy
Time frame: 3 years after enrollment
Improvement of glandular atrophy at the corpus lesser curvature
Incidence of metachronous gastric cancer
Time frame: 3 years after last patient enrollment
Comparison of metachronous gastric cancer according to the allocated treatment
2 secondary outcomes
Incidence of new gastric dysplasia
Time frame: 3 years after last patient enrollment
Overall survival
Time frame: 3 years after last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 29562147Choi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Il Ju Choi, MD, PhD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin in people with Helicobacter Pylori Infection and Early Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement (histological) of glandular atrophy (time frame: 3 years after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.