Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy.
May Elbanna, Kevin Shiue, Donna Edwards...
https://pubmed.ncbi.nlm.nih.gov/32736936Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02984761
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)
Led by VA Office of Research and Development · Updated on 2026-02-19
670
Participants Needed
17
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two treatments for patients with stage I non-small cell lung cancer who are fit enough for surgery. The study evaluates surgical removal of the lung tumor versus stereotactic radiotherapy, a high-dose targeted radiation therapy. The goal is to determine which treatment may offer better overall survival over more than five years, as previous studies have shown conflicting results regarding their effectiveness. Participants will be randomly assigned to one of two groups. One group will receive stereotactic radiotherapy, with dosing depending on tumor location, delivered in 3 to 5 outpatient sessions. The other group will undergo surgery involving removal of a lung section and lymph nodes, with possible additional therapies if cancer is found in lymph nodes. The study includes multi-disciplinary evaluations and requires specific imaging and biopsy tests before treatment. During the study, patients will be monitored for at least five years. Researchers will assess overall survival, lung cancer mortality, quality of life, respiratory function, tumor patterns, and health state utilities. Follow-up includes imaging tests, biopsies, and clinical evaluations to track treatment effects and safety. The total participation time may last up to ten years as outcomes are reviewed.
CONDITIONS
Brief Title
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Preliminary diagnosis or biopsy-proven stage I non-small cell lung cancer
- Primary lung tumor size 5 cm or smaller
- Karnofsky performance status of 70 or higher
- Ability and willingness to provide informed consent
- Case reviewed by a multidisciplinary conference
- Tumor located at least 1 cm away from certain central structures
- FDG-PET/CT scan within 60 days before randomization
- Biopsy of lymph nodes larger than 10 mm with high SUV on PET/CT
- Biopsy of any suspicious lesions on PET/CT
- Pre-operative lung function with FEV1 and DLCO at least 40% of predicted
- Medically fit for anatomic pulmonary resection as judged by a thoracic surgeon
- Eligible for stereotactic radiotherapy as judged by a radiation oncologist
- Willingness to be randomized
You will not qualify if you...
- Medically inoperable as determined by a thoracic surgeon
- Confirmed nodal or distant metastasis
- Prior history of lung cancer (other than current lesion)
- Prior thoracic surgery or lung/esophageal cancer (except cardiac surgery)
- Prior thoracic radiotherapy
- Invasive malignancy (stage I-III) treated within past 2 years, except certain low-risk cancers
- Prior intravenous malignancy except specific types
- Ever diagnosed with stage IV metastatic cancer
- History of scleroderma
- Positive pregnancy test in 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo mandatory evaluations including tissue confirmation of lung cancer, FDG-PET/CT staging, and biopsies of lymph nodes as needed before randomization.
Treatment
Duration - Stereotactic radiotherapy delivered in 3 to 5 outpatient treatment sessions; surgery requires a short hospital stay for anatomic pulmonary resection under general anesthesia.
Participants receive either stereotactic radiotherapy or surgical removal of the lung tumor with lymph node sampling.
3 to 5 outpatient visits for radiotherapy or 1 hospital stay for surgery
Follow-up
Duration - At least 5 years
Participants are followed for a minimum of 5 years after treatment to monitor overall survival, lung cancer outcomes, respiratory function, and quality of life.
Regular visits for ongoing assessments over 5 years
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
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Research Team
D
Drew Moghanaki, MD MPH
V
Vicki L Skinner, RN
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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