Post-Treatment Surveillance in Lung Cancer

NCT ID: NCT03475420

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9613 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2016-12-31

Brief 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.

Detailed Description

This study will use a special study of the National Cancer Database to develop a cohort of NSCLC survivors undergoing surveillance. Cox proportional hazards regression and competing risk analyses will compare the effectiveness of the three most common surveillance intensities (3 months vs. 6 months vs. annually) on survival.

There is also a plan to engage cancer survivors to guide the development of our study comparators, outcomes and demonstration of results.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

National Cancer Database

Use existing data to define surveillance strategy in use for patients in this cohort. We will use 10 randomly selected lung cancer resection patients from each accredited institution with stage I-III NSCLC (potentially curative resection) diagnosed in 2006-2007 and with 5 years of complete follow up or reported as deceased before 2012.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Men or Women
• Diagnosis of surgically resected lung cancer
• American Joint Committee On Cancer (AJCC) stages I-III

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Kozower, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

17624

Identifier Type: -

Identifier Source: org_study_id