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Non Small Cell Lung CancerSORTNCT05183932

Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer

An observational study of Non Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Washington University School of Medicine at 8 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. Read more about this study

Who is it for?
Ages 18 years and older
How many people
446 participants
Where
8 sitesin 2 countries
Study dates
14 Jul 2022to 31 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants who meet the eligibility criteria from any of the participating sites listed.

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • "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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States7 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University

    Durham, North Carolina, 27710

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Carle Cancer Institute

    Urbana, Illinois, 61801

Other trials in United States

Canada1 site

  • University of Toronto

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Comparing the Effectiveness of Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer (SORT)

The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05183932
Study groupRoleWhat they receive
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
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier.

    Measured: Through 36 months post-treatment (estimated to be 36 months and 1 week)

  2. Change in patient-reported outcomes as measured by the PROMIS Bank survey

    • Surveys will occur at baseline, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment
    • The PROMIS scores will be compared across the 8 pre-specified domains:
    • Cancer Bank v1.1 - Physical Function
    • Cancer Bank v1.1 - Pain Interference
    • Cancer Bank v1.0 - Fatigue
    • Cancer Bank v1.0 - Depression
    • Cancer 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
    • PROMIS is scored 1-100 and normalizes to the population mean of 50 with each 10 being a standard deviation. A higher score indicates a worse patient-reported outcome.

    Measured: From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)

Secondary outcomes (4)

  1. Cancer-specific survival (CSS)

    Cancer-specific survival (CSS) is defined as time from the date of treatment to date of cancer-related death. The alive patients without any signs or symptoms of that cancer are censored at the last follow-up.

    Measured: Through 36 months post-treatment (estimated to be 36 months and 1 week)

  2. Overall survival (OS)

    Overall survival (OS) is defined as time from the date of treatment to date of death. The alive patients are censored at the last follow-up.

    Measured: Through 36 months post-treatment (estimated to be 36 months and 1 week)

  3. Treated-related mortality

    Measured: At 30 days (estimated to be 1 month and 1 week)

  4. Number of post-treatment events (grade 3 and above)

    Post-treatment grade 3-5 events measured via CTCAE version 5.0

    Measured: Through 36 months post-treatment (estimated to be 36 months and 1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start14 Jul 2022
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183932
Sponsor's protocol ID
202112102
Other IDs
R01CA258681
Acronym
SORT
Status last verified
Apr 2026
First submitted
21 Dec 2021
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Washington University School of Medicine at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: Through 36 months post-treatment (estimated to be 36 months and 1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05183932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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