Lung cancer showdown: surgery or radiation – which saves more lives?

NCT ID NCT02468024

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for early-stage lung cancer in patients who are high-risk for surgery: removing part of the lung (sublobar resection) versus precise, high-dose radiation (stereotactic ablative radiotherapy). About 272 participants will be randomly assigned to one treatment. The main goal is to see if radiation leads to better 3-year survival than surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: radiation therapy (stereotactic ablative radiotherapy) and lung surgery (sublobar resection)
What this could lead to: If radiation proves better than surgery, it could offer a less invasive, effective treatment option for high-risk patients with early-stage lung cancer.
What could go wrong: This is a large phase 3 trial, but results may not apply to all patients. Both treatments have risks, and radiation may not improve survival as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2015

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1.0 Inclusion Criteria 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. 1.4 The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization. 1.5 Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen performed within 180 days prior to randomization (reference Appendix A \& B). Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms. 1.6 All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (\> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within 180 days of randomization. 1.7 Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection. 1.8 Tumor located peripherally within the lung. NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See bronchial tree diagram below. Patients with non-peripheral (central) tumors are NOT eligible. 1.9 No evidence of distant metastases. 1.10 Availability of pulmonary function tests (PFTs - spirometry, DLCO, +/- arterial blood gases) within 180 days prior to registration. Patients with tracheotomy, etc, who are physically unable to perform PFTs (and therefore cannot be tested for the Major criteria in 3.1.11 below) are potentially still eligible if a study credentialed thoracic surgeon documents that the patient's health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection). 1.11 To define eligibility of patients being at high risk for surgery, certain criteria must be met. Any one (1) of the following major criteria will define the high risk status for eligibility: Major Criteria * FEV1 ≤ 50% predicted (pre-bronchodilator value) * DLCO ≤ 50% predicted (pre-bronchodilator value) * Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons. The belief must be declared and documented in the medical record prior to randomization. If any of the major criteria are met, the patient is eligible based on high risk for surgery and minor criteria do not need to be considered. However, if no major criteria is met, at least two (2) minor criteria being met will also define eligibility for meeting the high risk status. Any two (2) of the following minor criteria will define the high risk status for eligibility: * Minor Criteria * Age ≥75 * FEV1 51-60% predicted (pre-bronchodilator value) * DLCO 51-60% predicted (pre-bronchodilator value) * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88% * pCO2 \> 45 mm Hg * Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3. 1.12 No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted to the ipsilateral side so long as possible radiation fields would not overlap. NOTE: Radiotherapy to the contralateral lung is allowed so long as it was completed more than 3 years prior to randomization and there is no overlap of radiation fields. 1.13 Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. 1.14 No prior lung resection on the ipsilateral side. 1.15 Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Peri-menopausal women must be amenorrheic \> 12 months prior to registration to be considered not of childbearing potential. 1.16 No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers). 1.17 Ability to understand and sign a written informed consent. 2.0 Exclusion Criteria 2.1 Age \<18 2.2 ECOG/Zubrod performance status (PS) greater than 3. 2.3 Radiographic findings with ground glass opacities and less than 50% solid component will be excluded. 2.4 The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization. 2.5 Tumor \> 5 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen and/or performed greater than 180 days prior to randomization. 2.6 Lymph node biopsy greater than 180 days prior to randomization. 2.7 Thoracic surgeon confirms unable to remove tumor with sublobar resection. 2.8 Tumor located non-peripheral (central) region of lung (see bronchial tree diagram in 3.1.8). 2.9 Evidence of distant metastases. 2.10 Pulmonary function test (PFT - spirometry, DLCO, +/- arterial blood gases) greater than 180 days prior to registration. Patients physically unable to perform PFT's, such as patients with tracheotomy, that do not have written documentation from study credentialed thoracic surgeon stating eligibility. 2.11 Patients that do not meet either Major criteria or Minor criteria. 2.12 Prior intra-thoracic radiation therapy on ipsilateral side. Radiotherapy to the contralateral lung completed less than 3 years prior to randomization, with radiation field overlap. 2.13 Prior chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol. 2.14 Prior lung resection on the ipsilateral side. 2.15 Pregnant and lactating women. 2.16 Prior invasive malignancy and less than 3 years disease free prior to registration (unless non-melanoma skin cancer, in-situ cancers). 2.17 Unable to understand and/ or sign a written informed consent.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

12 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Allegheny
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Barwon Health - Uni Hospital Geelong
RECRUITING

Geelong, Victoria, 3220, Australia
Beaumont
COMPLETED

Royal Oak, Michigan, 48073, United States
Boca Raton Regional Hospital
COMPLETED

Boca Raton, Florida, 33486, United States
Boston Medical Center
COMPLETED

Boston, Massachusetts, 02118, United States
CHUM
RECRUITING

Montreal, Quebec, 26214, Canada
Cardiothoracic and Vascular Surgeons
COMPLETED

Austin, Texas, 78756, United States
Case Western (University Hospitals Case Medical Center)
COMPLETED

Cleveland, Ohio, 44106, United States
Clement Zablocki VA Medical Center
COMPLETED

Milwaukee, Wisconsin, 53295, United States
Cleveland Clinic
ACTIVE_NOT_RECRUITING

Cleveland, Ohio, 44195, United States
Curtis and Elizabeth Anderson Cancer
RECRUITING

Savannah, Georgia, 31404, United States
Henry Ford Health System
COMPLETED

Detroit, Michigan, 48202-2689, United States
Inova Fairfax Medical Campus
COMPLETED

Falls Church, Virginia, 22042, United States
Intermountain Medical Center
COMPLETED

Salt Lake City, Utah, 84107, United States
Lawson Health Science Center
RECRUITING

London, Ontario, Canada, N6C 2R5, Canada
Lifespan Oncology Clinical Research
COMPLETED

Providence, Rhode Island, 02903, United States
Luminis Health Research Institute
ACTIVE_NOT_RECRUITING

Annapolis, Maryland, 21401, United States
Mayo Clinic Rochester
COMPLETED

Rochester, Minnesota, 55905, United States
Medical College of Wisconsin
COMPLETED

Milwaukee, Wisconsin, 53226, United States
Meridian Health System
RECRUITING

Neptune City, New Jersey, 07753, United States
Mount Nittany
COMPLETED

State College, Pennsylvania, 16803, United States
New York University Langone Medical Center
ACTIVE_NOT_RECRUITING

New York, New York, 10016, United States
Ochsner Medical Center
COMPLETED

New Orleans, Louisiana, 70121, United States
Ohio State University Wexner Medical Center
ACTIVE_NOT_RECRUITING

Columbus, Ohio, 43210, United States
Ottawa Hospital Cancer Center
RECRUITING

Ottawa, Ontario, KIH8L6, Canada
Penrose Cancer Center
COMPLETED

Colorado Springs, Colorado, 80907, United States
Providence Health & Services/Oregon Clinic
COMPLETED

Portland, Oregon, 97213, United States
SUNY - Upsate Medical Centre
RECRUITING

Syracuse, New York, 13210, United States
St. Vincent's Hospital Melbourne
RECRUITING

Fitzroy, Melbourne, 3065, Australia
St. Vincent's/Peter Mac
RECRUITING

Fitzroy, Victoria, 3065, Australia
Sunnybrook Health Sciences Centre
COMPLETED

Toronto, Canada, M4N 3M5, Canada
Swedish Cancer Institute
COMPLETED

Seattle, Washington, 98104, United States
The James Cook University Hospital
ACTIVE_NOT_RECRUITING

Middlesbrough, TS4 2BW, United Kingdom
Thomas Jefferson University
COMPLETED

Philadelphia, Pennsylvania, 19107, United States
Trillium Health Partners
COMPLETED

Mississauga, Canada, L5M 2N1, Canada
UCSD
COMPLETED

La Jolla, California, 92023, United States
UHN-Toronto
RECRUITING

Toronto, Ontario, M5G2C4, Canada
UPMC Health System
COMPLETED

Pittsburgh, Pennsylvania, 15234, United States
University of Cincinnati
COMPLETED

Cincinnati, Ohio, 45267, United States
University of Colorado/Memorial
COMPLETED

Aurora, Colorado, 80045, United States
University of Iowa
TERMINATED

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
COMPLETED

Kansas City, Kansas, 66160, United States
University of Kentucky Health Care
COMPLETED

Lexington, Kentucky, 40536-0093, United States
University of Louisville Physicians
ACTIVE_NOT_RECRUITING

Louisville, Kentucky, 40202, United States
University of Maryland Medical Center
COMPLETED

Baltimore, Maryland, 21201, United States
University of North Carolina
COMPLETED

Chapel Hill, North Carolina, 27599, United States
University of Tennessee Health Science Center
COMPLETED

Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
University of Virginia Health System
COMPLETED

Charlottesville, Virginia, 22901, United States
Wake Forest Baptist Health
COMPLETED

Winston-Salem, North Carolina, 27157, United States

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