Trial Information

A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer

OBJECTIVES: I. Determine the efficacy of a lung cancer risk assessment questionnaire
combined with spirometry testing in identifying a statistically significant number of
persons with high-risk behaviors for the development of lung cancer. II. Determine the
sensitivity of these screening techniques in identifying a population at high risk for the
development of lung cancer. III. Determine the number of patients necessary to screen in
order to identify the high-risk population eligible for this study. IV. Determine the lead
time bias of CT scans versus chest x-rays in these patients. V. Determine the efficacy of
spiral CT scanning of the chest in detecting early lung cancers not visible on chest x-rays
in patients at high risk for lung cancer. VI. Compare annual spiral CT scanning versus
annual chest x-rays in detecting lung cancer in these patients. VII. Compare survival and
fatality in these patients with these detection methods.

OUTLINE: Patients are randomized to one of two screening arms. Arm I: Patients receive
routine medical care, an annual nursing assessment, and an annual chest x-ray. Any new
abnormality identified is further evaluated through standard acceptable medical
interventions. Arm II: Patients receive routine medical care, an annual nursing assessment,
and an annual spiral CT scan of the chest. If an abnormal mass greater than 10 mm in
diameter or 5-10 mm in diameter and highly suspicious for malignancy is detected, chest
x-ray and tissue diagnosis is obtained. If the abnormal mass is 10 mm or less in diameter, a
thin section high resolution image of the mass is obtained. If this image is normal or
benign, annual spiral CT scanning is continued. If the image is indeterminate, a repeat high
resolution scan is performed in 3 months. If the image is unchanged at 3 months, annual
spiral CT scanning is continued. If the mass is larger at 3 months, chest x-ray and tissue
diagnosis is performed. Screening continues for 5 years in the absence of disease detection.

PROJECTED ACCRUAL: A minimum of 1,000 patients (500 per screening arm) will be accrued for
this study.