Know Cancer

or
forgot password

A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer


N/A
40 Years
70 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Renato V. LaRocca, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Kentuckiana Cancer Institute, PLLC

Authority:

United States: Federal Government

Study ID:

CDR0000068079

NCT ID:

NCT00006087

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms

Name

Location

Jewish HospitalLouisville, Kentucky  40202-1886