A Phase 3 interventional study of Proton pump inhibitor and Placebo in Gastric Cancer and Bleeding, sponsored by National Cancer Center, Korea. Terminated at 4 sites in Korea, Republic of. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by National Cancer Center, Korea · Phase 3, Interventional, and Prevention
The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 394 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Proton pump inhibitor (lansoprazole) therapy for the prevention of gastric cancer bleeding
Drug: Proton pump inhibitor
Placebo for the prevention of gastric cancer bleeding
Drug: Placebo
Lansoprazole 30 mg, daily
Also known as: Lansoprazole
Placebo, daily
Time-to-bleeding event
Evaluation of the effect of PPI on the prevention of gastric cancer bleeding
Time frame: Up to 6 years of study period
Transfusion requirement (packed RBC unit)
Unit of packed RBC required at the time of tumor bleeding
Time frame: Up to 6 years of study period
Number of endoscopy to evaluate tumor bleeding
No of endoscopic session to evaluation bleeding from advanced gastric cancer
Time frame: Up to 6 years of study period
Number of endoscopic treatment for cancer bleeding
Total number of endoscopic treatment perfomed for gastric cancer bleeding in each patient
Time frame: Up to 6 years of study period
Overall survival
Time frame: Up to 6 years of study period
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea