chest x-ray or chest ct scan in patients at high risk of developing lung cancer

Conditions: Lung Cancer

Summary: rationale: diagnostic procedures such as chest x-ray and chest ct scans may be effective in early detection of lung cancer. purpose: randomized clinical trial to compare the effectiveness of a chest ct scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing 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.

Eligibility criteria:
disease characteristics: patients at high risk for the development of lung cancer as defined by the following: at least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry fev-1/fvc ratio less than 70% predicted or fev-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference normal or stable current chest x-ray patient characteristics: age: 40 to 70 performance status: not specified life expectancy: at least 5 years hematopoietic: not specified hepatic: not specified renal: not specified pulmonary: see disease characteristics other: no other comorbidity that limits life span to less than 5 years no prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix not pregnant negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: non-small cell lung cancer small cell lung cancer