RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease. PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

Condition
Small Cell Lung Cancer screening for lung cancer Non-small cell lung cancer

Further Study Details: 

OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer.

PROTOCOL OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam.

PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.

Ages Eligible for Study:  55 Years   -   74 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Patient Characteristics--

• Age: 55 to 74
• Patients with a cigarette smoking history of at least 30 pack-years; Current smoker OR Smoker who has quit smoking within the past 10 years
• No known prior history of lung cancer

--Prior/Concurrent Therapy--

• No concurrent therapy for any cancer except nonmelanomatous skin cancer
• No prior removal of any portion of the lungs
• No concurrent participation in other cancer screening trial, including PLCO
• No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States

Study chairs or principal investigators

John K. Gohagan,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000068258; NCI-LUNG; NCI-P00-0171
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006382
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08