RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for lung cancer. It is not yet known whether helical computed tomography is more effective than chest x-ray in reducing death from lung cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of helical computed tomography with that of chest x-ray in screening individuals who are at high risk for lung cancer.

Condition	Treatment or Intervention
Small Cell Lung Cancer Non-small cell lung cancer	Procedure: comparison of screening methods  Procedure: computed tomography  Procedure: diagnostic radiology  Procedure: diagnostic test  Procedure: screening intervention  Procedure: study of high risk factors

Further Study Details: 

OBJECTIVES: Primary:

• Determine whether lung cancer screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer.

Secondary:

• Compare all-cause mortality between screenings with CT scan vs chest radiographs.
• Compare the differences in stage distribution between the two arms of the study.
• Compare lung cancer-related medical resource utilization between the two arms of the study.
• Compare the issues of quality of life and psychological impact associated with annual screening and with a positive screening test between the two arms of the study.
• Assess the economic consequences of screening with CT scan vs chest radiograph.
• Develop a tissue bank from individuals at high risk of lung cancer both with and without pathologically proven lung cancers, which would serve as a resource for determining biomolecular markers of high predictive value in stratifying levels of lung cancer risk, such as pre-malignancy (risk of future development of lung cancer), subclinical lung cancer, and advanced disease.
• Assess the impact of screening on smoking behaviors.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms.

Participants undergo spirometry at baseline for assessment of risk profile.

• Arm I: Participants undergo helical CT scan.
• Arm II: Participants undergo chest x-ray. Participants in both arms undergo screening initially and then annually for 2 years.

Quality of life is assessed at baseline, 1 month after the screening test, and then every 6 months for up to 6-8 years.

Health status and medical resource utilization are assessed every 6-12 months for up to 6-8 years.

The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored activities, the NCI Lung Screening Study I and the American College of Radiology Imaging Network (ACRIN). For more information, please access the NLST trial on Cancer.gov. The protocol ID is NCI-NLST.

PROJECTED ACCRUAL: A total of 50,000 participants will be accrued for this study within 2 years.

Ages Eligible for Study:  55 Years   -   74 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Current or prior cumulative cigarette smoking history of at least 30 pack years (packs per day multiplied by the number of years smoked)
• Former smokers must have quit smoking within the past 15 years
• No concurrent symptoms suggestive of lung cancer, including the following:
• Unexplained weight loss of over 15 pounds within the past 12 months
• Unexplained hemoptysis
• No prior diagnosis of lung cancer

PATIENT CHARACTERISTICS: Age:

• 55 to 74

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Pulmonary:

• No requirement for home oxygen supplementation
• No pneumonia or acute respiratory infection treated with antibiotics within the past 12 weeks

Other:

• No metallic implants or devices in the chest or back (e.g., pacemakers or Harrington fixation rods)
• No medical condition or disability that would pose a significant risk of mortality
• No medical or psychiatric condition that would preclude informed consent
• No other cancer within the past 5 years except nonmelanoma skin cancer or carcinomas in situ
• Melanoma and in situ transitional cell or bladder carcinomas are exclusionary
• Able to lie flat on back with arms raised over the head for up to 30 minutes

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 months since prior cytotoxic agents for any condition

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• No prior removal of any portion of the lung, excluding percutaneous lung biopsy

Other:

• At least 18 months since prior chest CT scan
• No concurrent participation in another cancer screening trial (e.g., Prostate-Lung-Colorectal-Ovarian Trial or Early Lung Cancer Action Project)
• No concurrent participation in a cancer prevention trial other than smoking cessation programs

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States
Iowa
      University of Iowa, Iowa City,  Iowa,  52242-1011,  United States
Kentucky
      Jewish Hospital, Louisville,  Kentucky,  40202-1886,  United States
Louisiana
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States
Massachusetts
      Beth Israel Deaconess Cancer Center at Waltham, Waltham,  Massachusetts,  02453,  United States
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0942,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
New Hampshire
      Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon,  New Hampshire,  03756-0002,  United States
New Jersey
      Cancer Institute of New Jersey at Hamilton, Hamilton,  New Jersey,  08690,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown, Youngstown,  Ohio,  44501,  United States
Pennsylvania
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Rhode Island
      Roger Williams Medical Center, Providence,  Rhode Island,  02908-4735,  United States
South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Denise R. Aberle, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   
John K. Gohagan, PhD, FACE,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000069136; ACRIN-6654; NCI-ACRIN-6654; NCI-NLST-ACRIN-6654
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028808
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08