The Use of Proton Pump Inhibitor on the Prevention of Gastric Cancer Bleeding
NCT ID: NCT02150447
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
394 participants
INTERVENTIONAL
2009-06-30
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention group
Proton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding
Proton pump inhibitor
Lansoprazole 30 mg, daily
Placebo group
Placebo for the prevention of gastric cancer bleeding
Placebo
Placebo, daily
Interventions
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Proton pump inhibitor
Lansoprazole 30 mg, daily
Placebo
Placebo, daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* 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)
18 Years
90 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Kosin University Gospel Hospital
OTHER
Gyeongsang National University Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Il Ju Choi
Head of Gastric Cancer Cencer
Principal Investigators
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Il Ju Choi, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Korea
Gwang Ha Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Moo In Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kosin University Gospel Hospital
Won Sup Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gyeongsang National University Hospital
Locations
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Kosin University Gospel Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
National Cancer Center
Goyang, , South Korea
Gyeong Sang National University Hospital
Jinju, , South Korea
Countries
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References
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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.
Other Identifiers
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0910090
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1210520
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCCCTS09420
Identifier Type: -
Identifier Source: org_study_id
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