Lung Cancer Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age > 18 years.
ECOG performance status (PS) 0, 1, or 2.
Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. Those with ground glass opacities and <50% solid component will be excluded.
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/CT scan of the chest and upper abdomen performed within 180 days prior to randomization. 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 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).
Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria

Major Criteria

FEV1 ≤ 50% predicted (pre-bronchodilator value)
DLCO ≤ 50% predicted (pre-bronchodilator value)

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
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.
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.
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 so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted.
No prior lung resection on the ipsilateral side.
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.
No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

evidence of distant metastases
prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap. Previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. No prior lung resection on the ipsilateral side.
pregnant and lactating women
prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

272

Study ID:

NCT02468024

Recruitment Status:

Recruiting

Sponsor:

University of Texas Southwestern Medical Center

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There are 48 Locations for this study

See Locations Near You

UCSD
La Jolla California, 92023, United States
University of Colorado/Memorial
Aurora Colorado, 80045, United States
Penrose Cancer Center
Colorado Springs Colorado, 80907, United States
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Curtis and Elizabeth Anderson Cancer
Savannah Georgia, 31404, United States More Info
Aaron Pederson, MD
Contact
912-350-8490
University of Iowa
Iowa City Iowa, 52242, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
University of Kentucky Health Care
Lexington Kentucky, 40536, United States
University of Louisville Physicians
Louisville Kentucky, 40202, United States More Info
Neal Dunlap, MD
Contact
502-588-6000
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Luminis Health Research Institute
Annapolis Maryland, 21401, United States More Info
Mary Young, MD
Contact
443-481-1000
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Boston Medical Center
Boston Massachusetts, 02118, United States More Info
Kimberley Mak, MD
Contact
[email protected]
Henry Ford Health System
Detroit Michigan, 48202, United States
Beaumont
Royal Oak Michigan, 48073, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Meridian Health System
Neptune New Jersey, 07753, United States More Info
Thomas Bauer, MD
Contact
[email protected]
New York University Langone Medical Center
New York New York, 10016, United States More Info
Benjamin Cooper, MD
Contact
[email protected]
SUNY - Upsate Medical Centre
Syracuse New York, 13210, United States More Info
Jeffrey Bogart, MD
Contact
[email protected]
Erin Bingham
Contact
[email protected]
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Case Western (University Hospitals Case Medical Center)
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States More Info
Robert Merritt, MD
Contact
614-293-8415
[email protected]
Providence Health & Services/Oregon Clinic
Portland Oregon, 97213, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Allegheny
Pittsburgh Pennsylvania, 15212, United States More Info
Benny Weksler, MD
Contact
[email protected]
UPMC Health System
Pittsburgh Pennsylvania, 15234, United States
Mount Nittany
State College Pennsylvania, 16803, United States
Lifespan Oncology Clinical Research
Providence Rhode Island, 02903, United States
University of Tennessee Health Science Center
Memphis Tennessee, 38163, United States
Cardiothoracic and Vascular Surgeons
Austin Texas, 78756, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Robert Timmerman, MD
Contact
214-645-8525
Robert Timmerman, MD
Principal Investigator
Intermountain Medical Center
Salt Lake City Utah, 84107, United States
University of Virginia Health System
Charlottesville Virginia, 22901, United States
Inova Fairfax Medical Campus
Falls Church Virginia, 22042, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Brian Louie, MD
Contact
206-215-6800
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
David Johnstone, MD
Contact
[email protected]
Clement Zablocki VA Medical Center
Milwaukee Wisconsin, 53295, United States More Info
Elizabeth Gore, MD
Contact
414-384-2000
Shelly Dufek
Contact
414-384-2000
[email protected]
St. Vincent's/Peter Mac
Fitzroy Victoria, 3065, Australia More Info
Gavin Wright, MD
Contact
[email protected]
Laura Castleden
Contact
[email protected]
Lawson Health Science Center
London Ontario, Canada, N6C 2, Canada More Info
Richard Malthaner
Contact
519-646-6005
Deb Lewis
Contact
519-646-6005
Ottawa Hospital Cancer Center
Ottawa Ontario, KIH8L, Canada More Info
Sebastien Gilbert, MD
Contact
[email protected]
Anna Fazekas
Contact
[email protected]
UHN-Toronto
Toronto Ontario, M5G2C, Canada More Info
Andrew Pierre, MD
Contact
416-340-3131
Jennifer Lister
Contact
416-340-3131
CHUM
Montréal Quebec, 26214, Canada More Info
Moishe Liberman, MD
Contact
514 890-8000
Adeline Jouquan
Contact
514 890-8000
Trillium Health Partners
Mississauga , L5M 2, Canada More Info
Anthony Brade, MD
Contact
(905) 813-2200
Sandy Phillips
Contact
[email protected]
Sunnybrook Health Sciences Centre
Toronto , M4N 3, Canada More Info
Patrick Cheung, MD
Contact
416-480-5000
Ilda Carvalhana
Contact
416-480-5000
The James Cook University Hospital
Middlesbrough , TS4 2, United Kingdom More Info
Joel Dunning, MD
Contact
[email protected]
Charlotte Jacobs
Contact
01642854974
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

272

Study ID:

NCT02468024

Recruitment Status:

Recruiting

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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