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Gastric CancerPhase 3NCT02150447

The Use of Proton Pump Inhibitor on the Prevention of Gastric Cancer Bleeding

A Phase 3 study testing Proton pump inhibitor in people with Gastric Cancer and Bleeding, run by National Cancer Center, Korea at 4 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Gastric Cancer, Bleeding
What is being tested?
Proton pump inhibitor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
394 participants
Where
4 sitesSouth Korea
Study dates
Jun 2009to May 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven primary gastric adenocarcinoma
  • Age ≥18 years
  • Plan for 1st line or 2nd line palliative chemotherapy
  • Cancer staging: metastatic (TxNxM1) or locally advanced unresectable gastric cancer (T4NxMx with unresectable), or T2-3NxMx with inoperable condition
  • Performance status (PS) of 0 to 2 on Eastern Cooperative Oncology Group (ECOG) scale
  • Adequate organ functions defined as indicated below: (a) WBC > 3000/mm3, (b) Hb 9.0 g/dL regardless of any transfusion history, (c) Platelet ≥100,000/mm3, (d) AST/ALT ≤ 2.5 x UNL (≤ 5 x UNL if liver metastases are present) (e) Total bilirubin ≤1.5x UNL (f) Cr ≤1.5 x UNL
  • Written informed consent

Who cannot join

  • Other malignancy within the past 3 years except adequately treated non-melanomatous skin cancer or carcinoma in situ of the cervix
  • Patients with significant or uncontrolled gastrointestinal bleeding in the past two weeks without evidence of resolution documented by endoscopy or colonoscopy
  • Previous subtotal gastrectomy or total gastrectomy
  • Patient with a plan for neo-adjuvant chemotherapy
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or inability to take oral medication
  • Allergy history to proton pump inhibitor
Show all 15Show fewer
  • Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  • Inadequate cardiovascular function: (a) New York Heart Association class III or IV heart disease, (b) Unstable angina or myocardial infarction within the past 6 months, (c) History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
  • Requirement for therapeutic anticoagulant therapy, aspirin or non-steroidal anti-inflammatory agents except COX-2 selective inhibitor
  • Requirement for therapeutic corticosteroid; the use of dexamethasone as anti-emetics or a premedication of chemotherapy-associated hypersensitivity is not an exclusion criteria
  • Need for PPI maintenance treatment for uncontrolled reflux esophagitis or active peptic ulcer
  • Psychiatric disorder that would preclude compliance
  • Pregnant or breast-feeding women
  • Untreated folate or vitamine B12 deficiency anemia
  • Bone marrow metastasis, or evidence of microangiopathic hemolytic anemia (MAHA)

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Kosin University Gospel Hospital

    Busan, 602-702

  • Pusan National University Hospital

    Busan, 620-739

  • National Cancer Center

    Goyang, 410-769

  • Gyeong Sang National University Hospital

    Jinju, 660-702

Other trials in South Korea

About this study

Official title: Effect of Proton Pump Inhibitor on Prevention of Tumor Bleeding in Patients Under Palliative Chemotherapy for Unresectable Gastric Cancer: a Randomized, Double Blind, and Placebo Controlled Multicenter Trial

The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients.

Read the detailed description

Tumor bleeding frequently occurs in inoperable gastric cancer patients. Inoperable gastric cancer usually has a large ulcer with friable tumor vessels. Acidic environment in stomach prevents adequate function of coagulation cascade and decrease clot stability. Gastric cancer bleeding may cause significant morbidity and often delays scheduled chemotherapy. National Center Center data showed that about 30% of gastric cancer patient undergoing palliative chemotherapy eventually experience significant cancer bleeding during the treatment period. Once bleeding occurs, endoscopic management is more difficult in gastric cancer patients than in patients with benign peptic ulcers, because the malignant ulcer bed has significant fibrosis. Consequently, gastric cancer patient has a high risk of rebleeding.

Proton pump inhibitor (PPI, lansoprazole for example) decrease gastric acid secretion by inhibiting H+,K+-ATPase, and subsequently stabilize blood clot. PPIs are commonly used for benign peptic ulcer or reflux esophagitis, and PPI can decrease recurrent benign ulcer bleeding or other ulcer complications. Moreover, it was reported to prevent bleeding from NSAID or aspirin induced gastric ulcer. Because PPIs are very safe, and they are even available as over-the-counter drugs in some countries. Furthermore, the drug has no interaction with major chemotherapeutic agents commonly used for gastric cancer. Moreover, the drugs are prescribed to the gastric cancer patients when tumor bleeding occurs. Although gastric cancer bleeding is not uncommon and clinically challenging problem, there has been no recommended measure to prevent cancer bleeding. Also there has been no report about the efficacy of PPIs on the gastric cancer bleeding prevention up to now.

Being tested
Proton pump inhibitor, Placebo
Keywords
Gastric cancer bleeding, Proton pump inhibitor
Medical subject headings
Stomach Neoplasms, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton pump inhibitorDrug

    Also called Lansoprazole

    Lansoprazole 30 mg, daily

  • PlaceboDrug

    Placebo, daily

Study groups in NCT02150447
Study groupRoleWhat they receive
Intervention groupActive comparatorProton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding
Receives: Drug: Proton pump inhibitor
Placebo groupPlacebo comparatorPlacebo for the prevention of gastric cancer bleeding
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-to-bleeding event

    Evaluation of the effect of PPI on the prevention of gastric cancer bleeding

    Measured: Up to 6 years of study period

Secondary outcomes (4)

  1. Transfusion requirement (packed RBC unit)

    Unit of packed RBC required at the time of tumor bleeding

    Measured: Up to 6 years of study period

  2. Number of endoscopy to evaluate tumor bleeding

    No of endoscopic session to evaluation bleeding from advanced gastric cancer

    Measured: Up to 6 years of study period

  3. Number of endoscopic treatment for cancer bleeding

    Total number of endoscopic treatment perfomed for gastric cancer bleeding in each patient

    Measured: Up to 6 years of study period

  4. Overall survival

    Measured: Up to 6 years of study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2014 (estimated)
  2. Study startJun 2009
  3. Primary completionApr 2015
  4. Study completionMay 2017

Why it stopped: Low enroll rate

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
394 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02150447
Sponsor's protocol ID
NCCCTS09420
Other IDs
0910090, 1210520
Status last verified
Apr 2018
First submitted
26 May 2014
Last updated
4 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim YI, Kim MJ, Park SR, Kim HK, Cho SJ, Lee JY, Kim CG, Kim GH, Park MI, Nam BH, Park YI, Choi IJ. Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial. J Gastric Cancer. 2017 Jun;17(2):120-131. doi: 10.5230/jgc.2017.17.e15. Epub 2017 May 31.

    PubMed 28680717

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Proton pump inhibitor in people with Gastric Cancer and Bleeding, run by National Cancer Center, Korea at 4 sites 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 15 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: stopped early, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study was stopped early (reason given: Low enroll rate). Results are not available in the source record.

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?

Time-to-bleeding event (time frame: Up to 6 years of study period). 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 NCT02150447, 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 4 Apr 2018.

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