JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer (STABLE-MATES)

April 14, 2026 updated by: Robert Timmerman, University of Texas Southwestern Medical Center

JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched cohort studies to be effective at controlling primary early lung cancer. Recent pooled analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have shown a significantly improved 3-year survival with SABR, giving further impetus for successful completion of a randomized trial .

Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.Patients will be accrued and followed for a minimum of 2-years after treatment.

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
  • Canada
    • Canada
      • Mississauga, Canada, Canada, L5M 2N1
        • Completed
        • Trillium Health Partners
      • Toronto, Canada, Canada, M4N 3M5
        • Completed
        • Sunnybrook Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, KIH8L6
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • UHN-Toronto
        • Contact:
          • Andrew Pierre, MD
          • Phone Number: 416-340-3131
        • Contact:
          • Jennifer Lister
          • Phone Number: 416-340-3131
    • Ontario, Canada
      • London, Ontario, Canada, Canada, N6C 2R5
        • Recruiting
        • Lawson Health Science Center
        • Contact:
          • Richard Malthaner
          • Phone Number: 519-646-6005
        • Contact:
          • Deb Lewis
          • Phone Number: 519-646-6005
    • Quebec
      • Montreal, Quebec, Canada, 26214
        • Recruiting
        • CHUM
        • Contact:
          • Moishe Liberman, MD
          • Phone Number: 514 890-8000
        • Contact:
          • Adeline Jouquan
          • Phone Number: 514 890-8000
  • United Kingdom
      • Middlesbrough, United Kingdom, TS4 2BW
        • Active, not recruiting
        • The James Cook University Hospital
  • United States
    • California
      • La Jolla, California, United States, 92023
        • Completed
        • UCSD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Completed
        • University of Colorado/Memorial
      • Colorado Springs, Colorado, United States, 80907
        • Completed
        • Penrose Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Completed
        • Boca Raton Regional Hospital
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Curtis and Elizabeth Anderson Cancer
        • Contact:
          • Aaron Pederson, MD
          • Phone Number: 912-350-8490
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Terminated
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Completed
        • University of Kentucky Health Care
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • University of Louisville Physicians
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Completed
        • Ochsner Medical Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Active, not recruiting
        • Luminis Health Research Institute
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Completed
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Completed
        • Henry Ford Health System
      • Royal Oak, Michigan, United States, 48073
        • Completed
        • Beaumont
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Completed
        • Mayo Clinic Rochester
    • New Jersey
    • New York
      • New York, New York, United States, 10016
        • Active, not recruiting
        • New York University Langone Medical Center
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Completed
        • University of North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Completed
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Completed
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Completed
        • Case Western (University Hospitals Case Medical Center)
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Completed
        • Providence Health & Services/Oregon Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Completed
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh, Pennsylvania, United States, 15234
        • Completed
        • UPMC Health System
      • State College, Pennsylvania, United States, 16803
        • Completed
        • Mount Nittany
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Completed
        • Lifespan Oncology Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Completed
        • University of Tennessee Health Science Center
    • Texas
      • Austin, Texas, United States, 78756
        • Completed
        • Cardiothoracic and Vascular Surgeons
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
          • Robert Timmerman, MD
          • Phone Number: 214-645-8525
        • Principal Investigator:
          • Robert Timmerman, MD
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Completed
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Completed
        • University of Virginia Health System
      • Falls Church, Virginia, United States, 22042
        • Completed
        • Inova Fairfax Medical Campus
    • Washington
      • Seattle, Washington, United States, 98104
        • Completed
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Completed
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Completed
        • Clement Zablocki VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 lung surgery
Sublobar Resection (SR)
Procedure: Lung Surgery
Sublobar Lung Resection
Other Names:
  • SR
Experimental: Arm 2 radiation therapy
Stereotactic Ablative Radiotherapy (SAbR)
Radiation: Radiation therapy
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
Other Names:
  • SAbR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
To test the hypothesis that the 3-year overall survival in high risk operable patients with Stage I NSCLC is greater in patient who undergo SAbR as compared to standard sublobar resection (SR).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 5 years
survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
5 years
toxicity as assessed toxicity using the Common Toxicity Criteria
Time Frame: 3 years
toxicity using the Common Toxicity Criteria
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Robert Timmerman, MD, UTSW Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimated)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 022015-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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