Chemoprevention of Gastric Cancer by Intervention With Helicobacter Pylori and Cyclooxygenase Pathway
Status:
Unknown status
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Gastric cancer is the second leading cause of cancer deaths in the World. In China, gastric
cancer exceeds all other cancer mortality except lung cancer. Helicobacter pylori infection
is an important cause of gastric cancer. We have previously started a randomized
placebo-controlled chemoprevention trial in Changle in 1994 to address the issue of whether
eradication of H. pylori alone is able to prevent or reduce the risk of gastric cancer. The
project involved 1600 subjects and is still ongoing. On the other hand, our laboratory
research indicated that an abnormally high expression of an enzyme cyclooxygenase-2 was found
in gastric cancer and inhibition of this enzyme by a new drug (specific cyclooxygenase-2
inhibitor) could kill the cancer cells. The same drug is approved now for use in treatment of
hereditary colon cancer syndrome (Familial Adenomatous Polyposis, FAP), in the same rationale
of tumour suppressive property of this drug. We are now initiating a second chemoprevention
study to assess the addition of this specific cyclooxygenase-2 inhibitor together with
eradication of H. pylori on prevention or reduction of the risk of gastric cancer and to
assess whether the combination can reverse pre-cancerous lesions in the stomach in the
high-risk population. The proposed site is Shangdong, China with very high prevalence of
pre-cancerous lesions in asymptomatic H. pylori carriers. We plan to recruit 1500 H. pylori
positive subjects for this randomized placebo-controlled study. H. pylori carriers will be
randomized to receive treatment for the infection or placebo, followed by specific COX-2
inhibitor or placebo for 3 years. The results will have significant impact on prevention of
gastric cancer on a national scale and worldwide.