Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- VA Office of Research and Development
- Interventions being studied
- Radiation: Stereotactic Radiotherapy; Procedure: Anatomic Pulmonary Resection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Inclusion Criteria for Screening
- Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\]
- Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
- Karnofsky performance status greater than or equal to 70
- Participant has willingness and ability to provided informed consent for participation Inclusion Criteria for Randomization
- Biopsy proven non-small cell lung cancer
- Participant's case reviewed at multidisciplinary conference
- Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
- Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).
- Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)
- Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT
- Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.
- Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.
- Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
- Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
- Participant willingness to be randomized
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- VA Long Beach Healthcare System, Long Beach, CALong Beach, California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California
- Bay Pines VA Healthcare System, Pay Pines, FLBay Pines, Florida
- Miami VA Healthcare System, Miami, FLMiami, Florida
- Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois
- Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, Maryland
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, Massachusetts
- VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
- Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, Minnesota
- Durham VA Medical Center, Durham, NCDurham, North Carolina
- Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.