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NCT02468024PHASE3Recruiting

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

University of Texas Southwestern Medical Center

Start Date

7/1/2015

Completion Date

12/1/2028

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Lung Surgery

RADIATION

Radiation therapy

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Conditions

Non-Small Cell Lung Cancer

Locations

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

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 40536-0093

United States

University of Louisville Physicians

Louisville, Kentucky 40202

United States

Ochsner Medical Center

New Orleans, Louisiana 70121

United States

Luminis Health Research Institute

Annapolis, Maryland 21401

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Henry Ford Health System

Detroit, Michigan 48202-2689

United States

Beaumont

Royal Oak, Michigan 48073

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Meridian Health System

Neptune City, New Jersey 07753

United States

New York University Langone Medical Center

New York, New York 10016

United States

SUNY - Upsate Medical Centre

Syracuse, New York 13210

United States

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

Providence Health & Services/Oregon Clinic

Portland, Oregon 97213

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Allegheny

Pittsburgh, Pennsylvania 15212

United States

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

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

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Clement Zablocki VA Medical Center

Milwaukee, Wisconsin 53295

United States

St. Vincent's Hospital Melbourne

Fitzroy, Melbourne 3065

Australia

St. Vincent's/Peter Mac

Fitzroy, Victoria 3065

Australia

Barwon Health - Uni Hospital Geelong

Geelong, Victoria 3220

Australia

Trillium Health Partners

Mississauga, Canada L5M 2N1

Canada

Sunnybrook Health Sciences Centre

Toronto, Canada M4N 3M5

Canada

Ottawa Hospital Cancer Center

Ottawa, Ontario KIH8L6

Canada

UHN-Toronto

Toronto, Ontario M5G2C4

Canada

Lawson Health Science Center

London, Ontario, Canada N6C 2R5

Canada

CHUM

Montreal, Quebec 26214

Canada

The James Cook University Hospital

Middlesbrough, TS4 2BW

United Kingdom