Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer
NCT ID: NCT05183932
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
444 participants
OBSERVATIONAL
2022-07-14
2029-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgery
* Participants will have standard of care lobectomy/segmentectomy/wedge resection. Decision for treatment will be made at the discretion of the treating physician.
* PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment
* Bank 2.0 - Physical Function
* Bank v1.1 - Pain Interference
* Bank v1.0 - Fatigue
* Bank v1.0 - Depression
* Bank v1.0 - Anxiety
* Bank v1.0 - Dyspnea Severity
* Bank v2.0 - Ability to Participate in Social Roles and Activities
* Bank v2.0 - Cognitive Function
No interventions assigned to this group
Stereotactic body radiotherapy (SBRT)
* Participants will have standard of care 1-10 fractions of radiation therapy. Decision for treatment will be made at the discretion of the treating physician.
* PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment
* Bank v2.0 - Physical Function
* Bank v1.1 - Pain Interference
* Bank v1.0 - Fatigue
* Bank v1.0 - Depression
* Bank v1.0 - Anxiety
* Bank v1.0 - Dyspnea Severity
* Bank v2.0 - Ability to Participate in Social Roles and Activities
* Bank v2.0 - Cognitive Function
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PET/CT is required within 90 days of screening except under circumstances where the clinical picture suggests, or biopsy confirms, a low-grade adenocarcinoma.
* Biopsy is strongly encouraged. In the event biopsy is not performed, rationale must be provided for performing empiric treatment.
* Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Pre-treatment mediastinal lymph node sampling by any technique is allowed but not required. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) are be eligible only if directed tissue biopsies of all abnormally identified areas are negative for cancer.
* First primary NSCLC on the ipsilateral side.
* At least 18 years of age.
* Clinically eligible for either treatment (surgical resection or SBRT). Because this is a pragmatic study and treatment decisions are at the discretion of the treating physicians and their patients, patients must be eligible for either treatment. To be considered eligible for either treatment, patients must have:
* ECOG performance status ≤ 2
* No home oxygen use
* FEV1 and DLCO ≥ 40% predicted
* No symptomatic congestive heart failure as documented by NYHA I-II functional classification
* Been deemed operable by a thoracic surgeon, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to operability, the surgeon must define what anticipated surgical approach and procedure would be undertaken.
* Been deemed treatable by a radiation oncologist with 10 or fewer fractions of SBRT, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to suitability for SBRT, the radiation oncologist must define which dose and fractionation would be undertaken.
* Ability to understand and willingness to sign an IRB-approved written informed consent document.
* Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).
Exclusion Criteria
* Clinically diagnosed or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
* Prior thoracic radiation therapy that would overlap with the lung cancer being treated on study.
* Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on study.
* Prior lung resection on the ipsilateral side positive for malignancy.
* Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.
* "Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels).
* Concurrent enrollment in a therapeutic trial for the index cancer.
* Synchronous primary lung cancer.
* Uncontrolled or symptomatic psychiatric condition.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benjamin D Kozower, M.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Carle Cancer Institute
Urbana, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Toronto
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sinisa Stanic, M.D.
Role: primary
Benjamin D Kozower, M.D., MPH
Role: primary
David Jones, M.D.
Role: primary
Ara Vaporciyan, M.D.
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202112102
Identifier Type: -
Identifier Source: org_study_id