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ACRIN 6654
Contemporary Screening for the Detection of Lung Cancer
Principal Investigator: Denise R. Aberle, M.D.
Co-Principal Investigators: William C. Black, M.D.
Jonathan G. Goldin M.D., Ph.D.
Edward Patz, M.D.
Ilana Gareen, Ph.D.
Protocol Statistician: Constantine Gatsonis, Ph.D.
Lead Biostatistician: JoRean D. Sicks, M.S.
Lead Data Manager: Pamela Harvey, M Mgt
Project Manager: Irene Mahon, R.N., M.P.H.
Abstract:
Lung cancer is now the most common cause of cancer death among women and men. Despite
considerable clinical research in multi-modality cancer treatment, there has been no significant
decrease in lung cancer-specific mortality over the past three decades. Approximately 80% of
lung cancers are of non-small cell histology, for which prognosis depends primarily upon tumor
stage at the time of diagnosis. Although overall survival rates with non-small cell carcinoma are
dismal, patients with surgical stage I disease may have 10-year survivals of up to 70%. This has
formed the rationale for early detection programs. Both chest radiographs and spiral computed
tomography (CT) have been used to screen for lung cancer. Thus far, however, neither test has
been shown to reduce lung cancer mortality. This project is a multicenter, randomized controlled
trial involving 23 sites across the nation and will enroll up to 25,000 individuals at high risk of
developing lung cancer. High risk will be defined by age 55-74 years with a current or previous
heavy smoking history equaling at least 30 pack years; former smokers must have quit within the
preceding 15 years. Prior to randomization, all sites will collect standardized eligibility data,
including health histories, smoking behavior, and sociodemographic data, and will complete
spirometry. The Experimental group at all sites will undergo screening with low dose helical CT.
The Control group at all sites will undergo screening with chest radiographs. Experimental and
Control arms will be screened annually for at least two incidence screens and will be followed
thereafter for up to a total of eight years to determine outcomes. All participants will be
contacted at six-month intervals to document interval health status and changes in smoking
behaviors. The primary endpoint of the trial is to determine which screening test is better at
reducing lung cancer-specific mortality. Secondary endpoints include: all cause mortality,
differences in stage distribution at diagnosis, and differences in cost and medical resource
utilization between the two arms. At some of the participating institutions, three additional study
aims will include: [1] the creation of a bank of specimens from well-characterized high-risk
cohorts that can be used to test future potential biomolecular markers of lung cancer; [2]
evaluation of the influence of screening on smoking behaviors; and [3] the evaluation of
screening on various issues of quality of life and anxiety.
For full protocol text and data forms, click here