Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer - Full Text View

Sponsor:	American College of Radiology Imaging Network
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028808

Purpose

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 detecting 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	Intervention
Lung Cancer	Procedure: comparison of screening methods Procedure: computed tomography Procedure: radiography Procedure: study of high risk factors

Study Type:	Interventional
Study Design:	Screening, Randomized, Active Control
Official Title:	Contemporary Screening for the Detection of Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2002

Detailed Description:

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.

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

Eligibility

Ages Eligible for Study:	55 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 for respiratory conditions
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) that would cause sufficient beam hardening artifact to degrade lung image quality
No medical condition or disability that would pose a significant risk of mortality
No medical or psychiatric condition that would preclude informed consent
No cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ
- Melanoma and transitional cell or bladder carcinoma in situ 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, Early Lung Cancer Action Project, or single-arm trials such as those of the Mayo Lung Trial, Jewish Heart and Lung Institute, or the Moffitt Lung Trial)
No concurrent participation in a cancer prevention trial other than smoking cessation programs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028808

Show 24 Study Locations

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069136, ACRIN-6654, NCI-ACRIN-6654
Study First Received:	January 4, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00028808 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

small cell lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on November 05, 2009