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Lung cancer showdown: surgery vs. radiation – which is better?

NCT ID NCT02984761

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study looks at two standard treatments for early-stage lung cancer: surgery and a precise type of radiation called stereotactic radiotherapy. About 670 veterans with stage I non-small cell lung cancer will take part. The goal is to see which treatment leads to longer survival and better quality of life.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 670 people

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

Started

Apr 2017

Expected to finish

Mar 2034

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

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.

Inclusion Criteria: Inclusion Criteria for Screening * Age 18 or older * Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\] * Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT) * Karnofsky performance status greater than or equal to 70 * Participant has willingness and ability to provided informed consent for participation Inclusion Criteria for Randomization * Biopsy proven non-small cell lung cancer * Participant's case reviewed at multidisciplinary conference * Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images) * Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images). * Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement) * Mandatory pathological assessment of any lymph nodes \>10mm with a SUV \>2.5 seen on FDG- PET/CT * Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy. * Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value. * Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed) * Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy * Participant willingness to be randomized Exclusion Criteria: Exclusion Criteria for Screening * Previously evaluated by a local thoracic surgeon and determined to be medically inoperable * Pathological confirmation of nodal or distant metastasis * Prior history of lung cancer, not including current lesion * Prior history of thoracic surgery or lung or esophageal cancer. \[prior cardiac surgery acceptable\] * Prior history of radiotherapy to the thorax * Prior history of invasive state I-III malignancy treated with surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy in the past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (less than or equal to 1 cm), follicular lymphoma, or chronic lymphocytic leukemia. * Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis. * Ever diagnosed with stage IV metastatic cancer of any type * History of scleroderma * Positive Pregnancy test (for women \<61 years of age or without prior hysterectomy) Exclusion Criteria for Randomization * Pathological confirmation of nodal or metastatic disease

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Conditions

The condition(s) this trial relates to.

bronchial neoplasm bronchogenic carcinoma lung disorder lung neoplasm neoplasm Neoplasms by Site non-small cell lung carcinoma respiratory system disorder respiratory tract neoplasm Thoracic Neoplasms

As listed by the trial registrant

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

Lung neoplasm

How to take part

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

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    RECRUITING

    Bay Pines, Florida, 33744-0000, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    RECRUITING

    Milwaukee, Wisconsin, 53295-0001, United States

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    TERMINATED

    Philadelphia, Pennsylvania, 19104-4551, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    RECRUITING

    Hines, Illinois, 60141-3030, United States

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    TERMINATED

    Richmond, Virginia, 23249, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106-1702, United States

  • Miami VA Healthcare System, Miami, FL

    RECRUITING

    Miami, Florida, 33125, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    RECRUITING

    Indianapolis, Indiana, 46202-2884, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    RECRUITING

    Ann Arbor, Michigan, 48105-2303, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    RECRUITING

    Boston, Massachusetts, 02130-4817, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    RECRUITING

    West Los Angeles, California, 90073-1003, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    TERMINATED

    Pittsburgh, Pennsylvania, 15240, United States

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