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Post-Treatment Surveillance in Lung Cancer

NCT03475420 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9613

Last updated 2018-03-23

No results posted yet for this study

Summary

There are 13.7 million Americans currently living with a history of cancer. With continued improvements in cancer treatment and increasing life expectancy, this number is expected to reach nearly 18 million within the next decade. The care of these cancer patients, including surveillance during the post-treatment survivorship phase, is an increasingly important major health care concern and expenditure. As the fourth leading diagnosis among cancer survivors, lung cancer is emerging as a chronic problem that currently affects over 450,000 Americans and is expected to grow by nearly 20% by 2022.

Lung cancer is the second most common cancer in the United States. Of the estimated 182,550 patients newly diagnosed with non-small cell lung cancer (NSCLC) this year, approximately 35% will present with localized disease and be eligible for curative resection. For patients with limited NSCLC, surgical resection is the most effective method of controlling the primary tumor and provides the best opportunity for cure. A recent analysis by this group demonstrated that the number of lung cancer resections has increased over the past decade, with over 45,000 lung cancer resections performed annually in the US.

This research will address a critical gap in knowledge because the optimal approach to post-treatment surveillance following lung cancer resection is unknown. The intensity of recommended surveillance visits ranges from every 3 months during the first two years to an annual visit. Imaging modalities range from CT scans to chest radiographs to no routine imaging for asymptomatic patients. The reason for these significant differences is a lack of quality data on lung cancer surveillance and clinical guidelines based largely on small retrospective analyses and expert opinion.

The National Cancer Data Base (NCDB) provides real world national lung cancer resection and surveillance data on over 70% of newly diagnosed lung cancers from more than 1,500 institutions. This study will compare the effectiveness of the three most common surveillance intensities (CT scans every 3 months vs. 6 months vs. annually) on the stakeholder selected outcome of survival. All analyses will be risk adjusted for differences in patient characteristics at baseline, including tumor characteristics, patient age, comorbid disease, and other potential confounders. Analyses will also be adjusted for the competing risk of death.

Conditions

Sponsors & Collaborators

  • Alliance for Clinical Trials in Oncology

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Benjamin Kozower, MD · University of Virginia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2016-12-31
Completion
2016-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475420 on ClinicalTrials.gov