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

April 2, 2018 updated by: Il Ju Choi, National Cancer Center, Korea

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 620-739
        • Pusan National University Hospital
      • Goyang, Korea, Republic of, 410-769
        • National Cancer Center
      • Jinju, Korea, Republic of, 660-702
        • Gyeong Sang National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Proton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding
Drug: Proton pump inhibitor
Lansoprazole 30 mg, daily
Other Names:
  • Lansoprazole
Placebo Comparator: Placebo group
Placebo for the prevention of gastric cancer bleeding
Drug: Placebo
Placebo, daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-bleeding event
Time Frame: Up to 6 years of study period
Evaluation of the effect of PPI on the prevention of gastric cancer bleeding
Up to 6 years of study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion requirement (packed RBC unit)
Time Frame: Up to 6 years of study period
Unit of packed RBC required at the time of tumor bleeding
Up to 6 years of study period
Number of endoscopy to evaluate tumor bleeding
Time Frame: Up to 6 years of study period
No of endoscopic session to evaluation bleeding from advanced gastric cancer
Up to 6 years of study period
Number of endoscopic treatment for cancer bleeding
Time Frame: Up to 6 years of study period
Total number of endoscopic treatment perfomed for gastric cancer bleeding in each patient
Up to 6 years of study period
Overall survival
Time Frame: Up to 6 years of study period
Up to 6 years of study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Pusan National University Hospital
Gyeongsang National University Hospital
Kosin University Gospel Hospital

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS09420
  • 0910090 (Other Grant/Funding Number: National Cancer Center, Korea)
  • 1210520 (Other Grant/Funding Number: National Cancer Center, Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Proton pump inhibitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe