Clinical trial · Interventional
The Use of Proton Pump Inhibitor on the Prevention of Gastric Cancer Bleeding
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
NCT02150447CI-TRIAL-00032339terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enroll rate
Summary
Brief summary (as posted)
The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Proton pump inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- Proton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding
- interventionNames
- Drug: Proton pump inhibitor
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Placebo for the prevention of gastric cancer bleeding
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Time-to-bleeding event
- timeFrame
- Up to 6 years of study period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
References
Publications (1)
- DERIVEDKim 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. PMID 28680717