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Name of the Trial

Phase III Randomized Chemoprevention Study of Selenium in Participants With Previously Resected Stage I Non-Small Cell Lung Cancer (ECOG-5597). See the protocol summary ³.

Principal Investigators

Dr. Daniel Karp Principal Investigator

Dr. Daniel David Karp, Eastern Cooperative Oncology Group; Dr. Omer Kucuk, Southwest Oncology Group; Dr. Randolph Marks, North Central Cancer Treatment Group; Dr. Michael R. Johnston, National Cancer Institute of Canada; Dr. Gerald H. Clamon, Cancer and Leukemia Group B; Dr. Steven Belinsky, Lovelace Respiratory Research Institute.

Why Is This Trial Important?

Lung cancer is responsible for more cancer deaths in America than breast cancer, colon cancer, and prostate cancer combined. In its earliest stages, non-small cell lung cancer (NSCLC) may be removed surgically with potentially curative results. However, the incidence of a second tumor developing in patients who have been treated surgically for early-stage NSCLC is about 20 to 30 percent.

In this study, researchers are investigating the ability of selenium to prevent the development of secondary lung tumors in patients with surgically removed, early-stage NSCLC. Selenium is an essential dietary mineral that has been shown in animal studies to inhibit the growth of tumors. It is also associated with reduced cancer incidence in some animal populations.

"Selenium may help prevent cancer through a number of different mechanisms," said Dr. Karp. "It is an essential component of the antioxidant enzyme glutathione peroxidase, which protects tissue from oxidative damage and may help stimulate apoptosis (cell death). Selenium may also play an anti-inflammatory role by blocking the 5-lipoxygenase pathway."

Who Can Join This Trial?

Researchers seek to enroll 1,960 patients 18 years of age and older who have had stage I NSCLC completely removed by surgery. See the list of eligibility criteria ⁴.

Where Is This Trial Taking Place?

Study sites in the United States and Canada are enrolling patients in this trial. See the list of study sites ⁵.

Contact Information

See the list of study contacts ⁵ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

Glossary Terms

A substance that protects cells from the damage caused by free radicals (unstable molecules made by the process of oxidation during normal metabolism). Free radicals may play a part in cancer, heart disease, stroke, and other diseases of aging. Antioxidants include beta-carotene, lycopene, vitamins A, C, and E, and other natural and manufactured substances.

A type of cell death in which a series of molecular steps in a cell leads to its death. This is the body’s normal way of getting rid of unneeded or abnormal cells. The process of apoptosis may be blocked in cancer cells. Also called programmed cell death.

A protein that speeds up chemical reactions in the body.

A substance found in plant and animal tissues that has many functions in a cell. These include activating certain enzymes and destroying toxic compounds and chemicals that contain oxygen.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.