Actively Recruiting
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Led by VA Office of Research and Development · Updated on 2026-02-19
670
Participants Needed
17
Research Sites
885 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Preliminary diagnosis of stage I non-small cell lung cancer by biopsy or imaging
- Primary tumor size 5 cm or less on CT or PET/CT
- Karnofsky performance status 70 or higher
- Ability and willingness to provide informed consent
- Biopsy-confirmed non-small cell lung cancer before randomization
- Case reviewed by multidisciplinary conference
- Tumor at least 1.0 cm away from trachea, esophagus, brachial plexus, proximal bronchial tree bifurcation, or spinal cord
- FDG-PET/CT performed within 60 days before randomization
- Pathological assessment of lymph nodes larger than 10 mm with SUV over 2.5 on PET/CT
- Biopsy of any suspicious lesions found on PET/CT
- Pre-operative FEV1 and DLCO at or above 40% of predicted values
- Medically fit for complete anatomic pulmonary resection (no wedge resection)
- Eligible for protocol-defined stereotactic radiotherapy
- Willingness to be randomized
You will not qualify if you...
- Medically inoperable as determined by a thoracic surgeon
- Pathological confirmation of nodal or distant metastasis
- History of prior lung cancer (excluding current lesion)
- History of thoracic surgery or lung/esophageal cancer (cardiac surgery allowed)
- Prior thoracic radiotherapy
- Invasive malignancy treated within past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (≤1 cm), follicular lymphoma, or chronic lymphocytic leukemia
- History of intravenous malignancy except follicular lymphoma, chronic lymphocytic leukemia, or hormone-sensitive prostate cancer confined to pelvis
- Diagnosis of stage IV metastatic cancer of any type
- History of scleroderma
- Positive pregnancy test for women under 61 years or without prior hysterectomy
- Pathological confirmation of nodal or metastatic disease before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Actively Recruiting
3
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744-0000
Actively Recruiting
4
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Actively Recruiting
5
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
6
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Actively Recruiting
7
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
9
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
10
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
11
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
12
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
13
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Terminated
14
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Terminated
15
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
16
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Terminated
17
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-0001
Actively Recruiting
Research Team
D
Drew Moghanaki, MD MPH
CONTACT
V
Vicki L Skinner, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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