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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 09/02/2008
Related Pages
Stomach (Gastric) Cancer Home Page 1
NCI's gateway for information about stomach (gastric) cancer.
Eliminating a Common Bacterium Reduces Risk of Second Gastric Cancer

Adapted from the NCI Cancer Bulletin, vol. 5/no. 16, August 5, 2008 (see the current issue 2).

Researchers in Japan have shown that when the bacterium Helicobacter pylori is eliminated in patients who are treated for early stage gastric cancer, the risk of developing a second gastric cancer decreases by two-thirds. Their report appeared the August 2, 2008, issue of The Lancet (see the journal abstract 3).

H. pylori infects the stomachs of approximately half the people in the world and has been clearly linked to stomach problems, including peptic ulcers and cancer. Previous studies in animals have shown a preventive effect when the bacterium is eliminated, but results in human studies have been inconclusive.

The latest report, published by the Japan Gast Study Group, comes from an open-label study that included 544 patients aged 20-79 who were either newly diagnosed with gastric cancer and planning to undergo endoscopic surgery, or who had recently undergone surgery for gastric cancer. All patients had confirmed H. pylori infection. Those randomized into the test group received a combination of the antibiotics lansoprazole, amoxicillin, and clarithromycin twice a day for a week to prevent cancer recurrence, while those in the control group received standard care but no antibiotics.

The bacterium was eliminated from approximately 75 percent of patients who received the antibiotic regimen, and approximately 5 percent of patients from the control group. The only adverse effects of the antibiotic group with notable occurrence were soft stools and diarrhea. After three years of endoscopic monitoring, second gastric cancers occurred in nine patients from the treated group and 24 patients from the control group.

An accompanying editorial 4 by Dr. Nicholas J. Talley of the Mayo Clinic in Jacksonville, Fla., discusses the benefits and drawbacks of widespread H. pylori screening and treatment, concluding, "Worldwide, gastric cancer kills more people [than colorectal cancer], and there is better evidence that H. pylori eradication can prevent mortality than there is for colonoscopy screening. Preventing gastric cancer by eradicating H. pylori in high-risk regions should be a priority."



Glossary Terms

colonoscopy (KOH-luh-NOS-koh-pee)
Examination of the inside of the colon using a colonoscope, inserted into the rectum. A colonoscope is a thin, tube-like instrument with a light and a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for signs of disease.
control group
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.
endoscopy (en-DOSS-koh-pee)
A procedure that uses an endoscope to examine the inside of the body. An endoscope is a thin, tube-like instrument with a light and a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for signs of disease.
gastric cancer (GAS-trik KAN-ser)
Cancer that forms in tissues lining the stomach. Also called stomach cancer.
Helicobacter pylori (HEEL-ih-koh-BAK-ter py-LOR-ee)
A type of bacterium that causes inflammation and ulcers in the stomach or small intestine. People with Helicobacter pylori infections may be more likely to develop cancer in the stomach, including MALT (mucosa-associated lymphoid tissue) lymphoma. Also called H. pylori.
randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
screening (SKREEN-ing)
Checking for disease when there are no symptoms. Since screening may find diseases at an early stage, there may be a better chance of curing the disease. Examples of cancer screening tests are the mammogram (breast), colonoscopy (colon), Pap smear (cervix), and PSA blood level and digital rectal exam (prostate). Screening can also include checking for a person’s risk of developing an inherited disease by doing a genetic test.
standard therapy (...THAYR-uh-pee)
In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.


Table of Links

1http://www.cancer.gov/cancertopics/types/stomach
2http://www.cancer.gov/ncicancerbulletin
3http://www.ncbi.nlm.nih.gov/pubmed/18675689
4http://www.ncbi.nlm.nih.gov/pubmed/18675670