Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Screening	Closed	55 to 74	NCI	ACRIN-6654 NCI-ACRIN-6654, NCT00028808

Objectives

Primary

1. 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

1. Compare all-cause mortality between screenings with CT scan vs chest radiographs.
2. Compare the differences in stage distribution between the two arms of the study.
3. Compare lung cancer-related medical resource utilization between the two arms of the study.
4. 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.
5. Assess the economic consequences of screening with CT scan vs chest radiograph.
6. 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.
7. Assess the impact of screening on smoking behaviors.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Denise Aberle, MD, Protocol chair		Ph: 310-794-8989; 888-798-0719

National Cancer Institute

John Gohagan, PhD, FACE, Protocol chair		Ph: 301-496-3855 Email: jg72p@nih.gov

Registry Information
Official Title		Contemporary Screening for the Detection of Lung Cancer
Trial Start Date		2002-07-08
Registered in ClinicalTrials.gov		NCT00028808
Date Submitted to PDQ		2001-11-08
Information Last Verified		2004-04-05
NCI Grant/Contract Number		CA080098

Back to Top