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

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborators: Gyeong Sang National University Hospital; Gyeongsang National University Hospital; Kosin University Gospel Hospital; Pusan National University Hospital
• Treatments: Dexlansoprazole; Lansoprazole; Proton Pump Inhibitors

Criteria

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)