Lung cancer showdown: surgery or radiation – which is better?
NCT ID NCT05183932
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 446 people with stage I non-small cell lung cancer who chose either surgery or stereotactic body radiation therapy (SBRT). Researchers will track cancer recurrence, survival, and quality of life for up to 3 years to see which treatment offers better outcomes. The goal is to provide clearer guidance for patients and doctors facing this decision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors and patients choose between surgery and radiation for early-stage lung cancer based on real-world outcomes.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient selection. It does not test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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446 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants who meet the eligibility criteria from any of the participating sites listed.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening. * 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: * Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carle Cancer Institute
Urbana, Illinois, 61801, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Duke University
Durham, North Carolina, 27710, United States
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Emory University
Atlanta, Georgia, 30322, United States
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Memorial Sloan Kettering
New York, New York, 10065, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Toronto
Toronto, Ontario, Canada
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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- Can a less extensive lung cancer surgery be just as effective?