Gastric CancerPhase 3NCT01678027
Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication
A Phase 3 study testing LAC triple therapy in people with Gastric Cancer and Helicobacter Pylori Infection, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Helicobacter Pylori Infection, Family Members
- What is being tested?
- LAC triple therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,838 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2004to Dec 2035
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
- Informed consent should be signed
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408
About this study
Official title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.
Read the detailed description
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.
- Being tested
- Placebo, LAC triple therapy
- Keywords
- Stomach neoplasm, Helicobacter pylori
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
LAC triple therapyDrug
Also called PPI-Clarithromycin containing triple therapy
Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for LAC triple therapy Receives: Drug: Placebo |
| LAC triple therapy | Active comparator | PPI (Lansoprazole), Clarithromycin, Amoxicilline Receives: Drug: LAC triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric cancer incidence
The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status.
Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
Measured: 6 years after last participant enrollment
Secondary outcomes (4)
Gastric dysplasia incidence
Incidence of gastric dysplasia according to the H. pylori treatment
Measured: 6 year after last participant enrollment
Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
Gastric cancer incidence between H. pylori treatment group and H. pylori uninfected group
Measured: 6 year after last participant enrollment
Gastric cancer incidence according to H. pylori status
Gastric cancer incidence between H. pylori eradicated group and H. pylori persistent group
Measured: 6 year after last participant enrollment
All-cause mortality
All-cause mortality between H. pylori treatment group and placebo group
Measured: 6 year after last participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startNov 2004
- Primary completionDec 2018
- Study completionDec 2035 (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 Gastric CancerStudies 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
- 1,838 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, M.D., Ph.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678027
- Sponsor's protocol ID
- NCCCTS04-103
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2012
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, Joo J. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666.
PubMed 31995688
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
- Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01678027
- Acronym / sponsor ID
- NCCCTS04-103
- Keywords
- Stomach neoplasm, Helicobacter pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,838 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Nov 2004
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2035 (estimated)
- First posted
- 3 Sep 2012 (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 evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.
Detailed description
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.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for LAC triple therapy |
| LAC triple therapy | Active comparator | Drug: LAC triple therapyPPI (Lansoprazole), Clarithromycin, Amoxicilline |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sibling or offspring of patients with gastric adenocarcinoma confirmed by EGD and biopsy
- Informed consent should be signed
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| PlaceboLansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week. | Drug | Placebo |
| LAC triple therapyAlso: PPI-Clarithromycin containing triple therapyLansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week. | Drug | LAC triple therapy |
Primary outcome
Gastric cancer incidence
Time frame: 6 years after last participant enrollment
The incidence of gastric cancer will be compared between the two arms as the participant assigned into either LAC treatment group or placebo group regardless the final H. pylori infection status. Currently, efficacy of LAC triple therapy shows about 75-85% eradication rate of the H. pylori.
4 secondary outcomes
Gastric dysplasia incidence
Time frame: 6 year after last participant enrollment
Gastric cancer incidence between H. pylori treatment and H. pylori uninfected groups
Time frame: 6 year after last participant enrollment
Gastric cancer incidence according to H. pylori status
Time frame: 6 year after last participant enrollment
All-cause mortality
Time frame: 6 year after last participant 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 31995688Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, Joo J. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666.
- Individual participant dataSharing planned: No
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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, M.D., Ph.D. 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 LAC triple therapy in people with Gastric Cancer and Helicobacter Pylori Infection, 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 2 inclusion and 11 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?
Gastric cancer incidence (time frame: 6 years after last participant enrollment). 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 NCT01678027, 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.