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

NCT02468024 | Recruiting Phase 3 DMC

• 1 other identifier: STU 022015-069
• Study Type: interventional
• Target: 272
• Locations: 4 countries
• Sites: 50

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  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 Outcomes (2)

• progression free survival

  5 years

• toxicity as assessed toxicity using the Common Toxicity Criteria

  3 years

Study Arms (2)

Arm 1 lung surgery

ACTIVE COMPARATOR

Sublobar Resection (SR)

Procedure: Lung Surgery

Arm 2 radiation therapy

EXPERIMENTAL

Stereotactic Ablative Radiotherapy (SAbR)

Radiation: Radiation therapy

Interventions

Lung Surgery PROCEDURE

Sublobar Lung Resection

Also known as: SR

Arm 1 lung surgery

Radiation therapy RADIATION

Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions

Also known as: SAbR

Arm 2 radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C).
• Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater.
• The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization.
• 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.
• 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.
• Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
• 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.
• No evidence of distant metastases.
• 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).
• 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)

You may not qualify if:

• Age \<18
• ECOG/Zubrod performance status (PS) greater than 3.
• Radiographic findings with ground glass opacities and less than 50% solid component will be excluded.
• The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization.
• 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.
• Lymph node biopsy greater than 180 days prior to randomization.
• Thoracic surgeon confirms unable to remove tumor with sublobar resection.
• Tumor located non-peripheral (central) region of lung (see bronchial tree diagram in 3.1.8).
• Evidence of distant metastases.
• 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.
• Patients that do not meet either Major criteria or Minor criteria.
• 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.
• Prior chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol.
• Prior lung resection on the ipsilateral side.
• Pregnant and lactating women.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (50)

UCSD

La Jolla, California, 92023, United States

COMPLETED

University of Colorado/Memorial

Aurora, Colorado, 80045, United States

COMPLETED

Penrose Cancer Center

Colorado Springs, Colorado, 80907, United States

COMPLETED

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

COMPLETED

Curtis and Elizabeth Anderson Cancer

Savannah, Georgia, 31404, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

TERMINATED

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

COMPLETED

University of Kentucky Health Care

Lexington, Kentucky, 40536-0093, United States

COMPLETED

University of Louisville Physicians

Louisville, Kentucky, 40202, United States

ACTIVE NOT RECRUITING

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

COMPLETED

Luminis Health Research Institute

Annapolis, Maryland, 21401, United States

ACTIVE NOT RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

COMPLETED

Boston Medical Center

Boston, Massachusetts, 02118, United States

COMPLETED

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

COMPLETED

Beaumont

Royal Oak, Michigan, 48073, United States

COMPLETED

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

COMPLETED

Meridian Health System

Neptune City, New Jersey, 07753, United States

RECRUITING

New York University Langone Medical Center

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

SUNY - Upsate Medical Centre

Syracuse, New York, 13210, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

COMPLETED

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

COMPLETED

University of Cincinnati

Cincinnati, Ohio, 45267, United States

COMPLETED

Case Western (University Hospitals Case Medical Center)

Cleveland, Ohio, 44106, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

Providence Health & Services/Oregon Clinic

Portland, Oregon, 97213, United States

COMPLETED

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

COMPLETED

Allegheny

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

UPMC Health System

Pittsburgh, Pennsylvania, 15234, United States

COMPLETED

Mount Nittany

State College, Pennsylvania, 16803, United States

COMPLETED

Lifespan Oncology Clinical Research

Providence, Rhode Island, 02903, United States

COMPLETED

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

COMPLETED

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

COMPLETED

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

COMPLETED

University of Virginia Health System

Charlottesville, Virginia, 22901, United States

COMPLETED

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

COMPLETED

Swedish Cancer Institute

Seattle, Washington, 98104, United States

COMPLETED

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

COMPLETED

Clement Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

COMPLETED

St. Vincent's Hospital Melbourne

Fitzroy, Melbourne, 3065, Australia

RECRUITING

St. Vincent's/Peter Mac

Fitzroy, Victoria, 3065, Australia

RECRUITING

Barwon Health - Uni Hospital Geelong

Geelong, Victoria, 3220, Australia

RECRUITING

Trillium Health Partners

Mississauga, Canada, L5M 2N1, Canada

COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5, Canada

COMPLETED

Ottawa Hospital Cancer Center

Ottawa, Ontario, KIH8L6, Canada

RECRUITING

UHN-Toronto

Toronto, Ontario, M5G2C4, Canada

RECRUITING

Lawson Health Science Center

London, Ontario, Canada, N6C 2R5, Canada

RECRUITING

CHUM

Montreal, Quebec, 26214, Canada

RECRUITING

The James Cook University Hospital

Middlesbrough, TS4 2BW, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.

  PMID: 32736936 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pulmonary Surgical Procedures; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Robert Timmerman, MD

  UTSW Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Neufeld, MBA

CONTACT

214-645-8525; sarah.hardee@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Surgery versus SAbR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 10, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (40); AU (3); CA (6); GB (1)