Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT02468024

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

Led by University of Texas Southwestern Medical Center · Updated on 2026-04-16

272

Participants Needed

50

Research Sites

700 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • ECOG/Zubrod performance status of 0, 1, or 2
  • Radiographic evidence consistent with non-small cell lung cancer, including lesions with 50% or more solid components
  • Biopsy confirmation of primary lung tumor as non-small cell lung cancer within 180 days before randomization
  • Tumor size 4 cm or less in maximum diameter, including clinical stage IA and selected IB by PET or PET-CT within 180 days before randomization
  • Negative mediastinal lymph nodes confirmed by biopsy within 180 days before randomization if suspicious
  • Tumor location suitable for sublobar resection as verified by a thoracic surgeon
  • Tumor located peripherally in the lung, at least 2 cm away from the proximal bronchial tree
  • No evidence of distant metastases
  • Available pulmonary function tests within 180 days prior to registration, or documented high-risk operability by thoracic surgeon if unable to perform tests
  • High-risk status for surgery defined by either one major criterion (FEV1 or DLCO ≤ 50%, or surgeon's assessment) or two minor criteria (age ≥ 75, FEV1 or DLCO 51-60%, pulmonary hypertension, poor left ventricular function, low arterial oxygen, elevated pCO2, or dyspnea scale ≥ 3)
  • No prior intra-thoracic radiation on the same side as the tumor
  • No prior chemotherapy, radiotherapy, or surgery for the current lung cancer
  • No prior lung resection on the same side
  • Non-pregnant and non-lactating; women of childbearing potential must have a negative pregnancy test
  • No prior invasive malignancy unless disease-free for 3 or more years
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • ECOG/Zubrod performance status greater than 3
  • Radiographic lesions with less than 50% solid component
  • Biopsy confirmation of lung cancer more than 180 days before randomization
  • Tumor larger than 5 cm or staging imaging older than 180 days before randomization
  • Lymph node biopsy older than 180 days before randomization
  • Tumor not removable by sublobar resection as confirmed by surgeon
  • Tumor located in central lung region (not peripheral)
  • Evidence of distant metastases
  • Pulmonary function tests older than 180 days before registration without surgeon's documentation
  • Not meeting defined major or minor high-risk criteria for surgery
  • Prior intra-thoracic radiation on the same side or recent overlapping contralateral radiation
  • Previous chemotherapy, radiotherapy, or surgery for the lung cancer treated in this study
  • Prior lung resection on the same side
  • Pregnant or lactating women
  • Prior invasive malignancy with less than 3 years disease-free interval
  • Unable to understand or sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

UCSD

La Jolla, California, United States, 92023

Completed

2

University of Colorado/Memorial

Aurora, Colorado, United States, 80045

Completed

3

Penrose Cancer Center

Colorado Springs, Colorado, United States, 80907

Completed

4

Boca Raton Regional Hospital

Boca Raton, Florida, United States, 33486

Completed

5

Curtis and Elizabeth Anderson Cancer

Savannah, Georgia, United States, 31404

Actively Recruiting

6

University of Iowa

Iowa City, Iowa, United States, 52242

Terminated

7

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Completed

8

University of Kentucky Health Care

Lexington, Kentucky, United States, 40536-0093

Completed

9

University of Louisville Physicians

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

10

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

Completed

11

Luminis Health Research Institute

Annapolis, Maryland, United States, 21401

Active, Not Recruiting

12

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Completed

13

Boston Medical Center

Boston, Massachusetts, United States, 02118

Completed

14

Henry Ford Health System

Detroit, Michigan, United States, 48202-2689

Completed

15

Beaumont

Royal Oak, Michigan, United States, 48073

Completed

16

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Completed

17

Meridian Health System

Neptune City, New Jersey, United States, 07753

Actively Recruiting

18

New York University Langone Medical Center

New York, New York, United States, 10016

Active, Not Recruiting

19

SUNY - Upsate Medical Centre

Syracuse, New York, United States, 13210

Actively Recruiting

20

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Completed

21

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

Completed

22

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Completed

23

Case Western (University Hospitals Case Medical Center)

Cleveland, Ohio, United States, 44106

Completed

24

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Active, Not Recruiting

25

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Active, Not Recruiting

26

Providence Health & Services/Oregon Clinic

Portland, Oregon, United States, 97213

Completed

27

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Completed

28

Allegheny

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

29

UPMC Health System

Pittsburgh, Pennsylvania, United States, 15234

Completed

30

Mount Nittany

State College, Pennsylvania, United States, 16803

Completed

31

Lifespan Oncology Clinical Research

Providence, Rhode Island, United States, 02903

Completed

32

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38163

Completed

33

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States, 78756

Completed

34

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

35

Intermountain Medical Center

Salt Lake City, Utah, United States, 84107

Completed

36

University of Virginia Health System

Charlottesville, Virginia, United States, 22901

Completed

37

Inova Fairfax Medical Campus

Falls Church, Virginia, United States, 22042

Completed

38

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Completed

39

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Completed

40

Clement Zablocki VA Medical Center

Milwaukee, Wisconsin, United States, 53295

Completed

41

St. Vincent's Hospital Melbourne

Fitzroy, Melbourne, Australia, 3065

Actively Recruiting

42

St. Vincent's/Peter Mac

Fitzroy, Victoria, Australia, 3065

Actively Recruiting

43

Barwon Health - Uni Hospital Geelong

Geelong, Victoria, Australia, 3220

Actively Recruiting

44

Trillium Health Partners

Mississauga, Canada, Canada, L5M 2N1

Completed

45

Sunnybrook Health Sciences Centre

Toronto, Canada, Canada, M4N 3M5

Completed

46

Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada, KIH8L6

Actively Recruiting

47

UHN-Toronto

Toronto, Ontario, Canada, M5G2C4

Actively Recruiting

48

Lawson Health Science Center

London, Ontario, Canada, Canada, N6C 2R5

Actively Recruiting

49

CHUM

Montreal, Quebec, Canada, 26214

Actively Recruiting

50

The James Cook University Hospital

Middlesbrough, United Kingdom, TS4 2BW

Active, Not Recruiting

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Research Team

S

Sarah Neufeld, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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