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

NCT02150447 | Terminated Phase 3 DMC

• 3 other identifiers: NCCCTS0942009100901210520
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Gastric Cancer; Bleeding

Keywords

Gastric cancer bleeding; Proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Time-to-bleeding event

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

  Up to 6 years of study period

Secondary Outcomes (4)

• Transfusion requirement (packed RBC unit)

  Up to 6 years of study period

• Number of endoscopy to evaluate tumor bleeding

  Up to 6 years of study period

• Number of endoscopic treatment for cancer bleeding

  Up to 6 years of study period

• Overall survival

  Up to 6 years of study period

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Proton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding

Drug: Proton pump inhibitor

Placebo group

PLACEBO COMPARATOR

Placebo for the prevention of gastric cancer bleeding

Drug: Placebo

Interventions

Proton pump inhibitor DRUG

Lansoprazole 30 mg, daily

Also known as: Lansoprazole

Intervention group

Placebo DRUG

Placebo, daily

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Pusan National University Hospital: collaborator
• Kosin University Gospel Hospital: collaborator
• Gyeongsang National University Hospital: collaborator

Study Sites (4)

Kosin University Gospel Hospital

Busan, 602-702, South Korea

Location

Pusan National University Hospital

Busan, 620-739, South Korea

Location

National Cancer Center

Goyang, 410-769, South Korea

Location

Gyeong Sang National University Hospital

Jinju, 660-702, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28680717 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Hemorrhage

Interventions

Proton Pump Inhibitors; Lansoprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Il Ju Choi, M.D., Ph.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

• Gwang Ha Kim, M.D., Ph.D.

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Moo In Park, M.D., Ph.D.

  Kosin University Gospel Hospital

  PRINCIPAL INVESTIGATOR

• Won Sup Lee, M.D., Ph.D.

  Gyeongsang National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastric Cancer Cencer

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: June 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2017
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

KR (4)