Sublobar Resection or Stereotactic Ablative Radiotherapy in Treating Patients with Stage I Non-small Cell Lung Cancer

Status: Active

Description

This phase III trial compares sublobar resection (surgery to remove a portion of a lobe) and stereotactic ablative radiotherapy to see how well they work in treating patients with stage I non-small cell lung cancer. Sublobar resection is a less invasive type of surgery for non-small cell lung cancer and may have fewer side effects and improve recovery. Stereotactic radiosurgery, also known as stereotactic ablation radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether sublobar resection is more effective than stereotactic ablative radiotherapy in treating patients with non-small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG)/Zubrod 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 of randomization
  • Tumor =< 4 cm maximum diameter, including clinical stage IA and selected IB by positron emission therapy (PET)/computed tomography (CT) scan of the chest and upper abdomen performed within 90 days prior to randomization
  • 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, endoscopic ultrasound (EUS)/endobronchial ultrasound (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; patients with non-peripheral (central) tumors are NOT eligible
  • No evidence of distant metastases
  • Availability of pulmonary function tests (PFTs – spirometry, diffusing capacity of the lungs for carbon monoxide [DLCO], +/- arterial blood gases) within 90 days prior to registration; patients with tracheotomy, etc, who are physically unable to perform PFTs 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 as described below: * Major criteria ** Forced expiratory volume in 1 second (FEV1) =< 50% predicted ** DLCO =< 50% predicted * Minor criteria ** FEV1 51-60% predicted ** DLCO 51-60% predicted ** Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm 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 partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88% ** Partial pressure of carbon dioxide (pCO2) > 45 mm Hg ** Modified medical research council (MMRC) dyspnea scale >= 3 ** 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
  • No 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
  • 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

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Tracey Elizabeth Schefter
Email: tracey.schefter@ucdenver.edu
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Jenifer Bunn
Phone: 719-776-2842

Georgia

Savannah
Memorial Health University Medical Center
Status: Active
Contact: Lisa Morgan
Phone: 912-350-8490

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Bryan G. Allen
Email: bryan-allen@uiowa.edu

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Teresa Roberts
Phone: 502-588-6000

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Mini J. Elnaggar
Email: melnaggar@ochsner.org

Maryland

Annapolis
Anne Arundel Medical Center
Status: Active
Contact: Mary E. Young
Phone: 443-481-1000

Massachusetts

Boston
Boston Medical Center
Status: Active
Contact: Hiran C. Fernando
Phone: 617-638-5600
Email: hiran.fernando@bmc.org

Michigan

Detroit
Henry Ford Hospital
Status: Active
Contact: Zane Taysir Hammoud
Phone: 800-436-7936

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Shanda Haley Blackmon
Email: Blackmon.Shanda@mayo.edu

New Jersey

Neptune
Jersey Shore Medical Center
Status: Active
Contact: Thomas Lee Bauer
Email: tbauer@meridianhealth.com

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Benjamin Thomas Cooper
Email: Benjamin.Cooper@med.nyu.edu
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Jeffrey Alan Bogart
Email: BogartJ@upstate.edu

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Zahra Mahbooba
Phone: 919-966-3381

Ohio

Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Sandra Lynne Starnes
Email: starnesl@ucmail.uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Philip Aaron Linden
Email: philip.linden@uhhospitals.org
Cleveland Clinic Foundation
Status: Active
Contact: Gregory M. M. Videtic
Email: videtig@ccf.org
University Hospitals Cleveland Medical Center
Status: Active
Contact: Philip Aaron Linden
Email: Philip.Linden@UHhospitals.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Terence Marques Williams
Phone: 800-293-5066
Email: Jamesline@osumc.edu

Oregon

Portland
Providence Portland Medical Center
Status: Active
Contact: John Rutherfoord Handy
Email: john.handy@providence.org

Pennsylvania

State College
Mount Nittany Medical Center
Status: Active
Contact: Courtney Kanagy
Phone: 814-238-8418

Rhode Island

Providence
Lifespan
Status: Active
Contact: Cynthia Leach
Phone: 401-444-8311

Tennessee

Memphis
University of Tennessee Health Science Center
Status: Active
Contact: Amy Lange
Phone: 901-448-2918

Texas

Austin
Cardiothoracic and Vascular Surgeons
Status: Active
Contact: Daniel Leite Fortes
Email: dfortes@ctvstexas.com
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Robert D. Timmerman
Phone: 214-645-7651
Email: robert.timmerman@utsouthwestern.edu

Utah

Murray
Intermountain Medical Center
Status: Active
Contact: David C. Griffin
Email: David.Griffin@imail.org

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Linda Williams Martin
Email: LM6YB@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Hiran C. Fernando
Email: Hiran.Fernando@inova.org

Washington

Seattle
Swedish Medical Center-First Hill
Status: Active
Contact: Andrew Wade Smith
Phone: 206-215-6800

Wisconsin

Milwaukee
Medical College of Wisconsin
Status: Active
Contact: David William Johnstone
Email: djohnstone@mcw.edu
Milwaukee VA Medical Center
Status: Active
Contact: Shelley Helen Dufek
Phone: 414-384-2000
Email: shelley.dufek@va.gov
Zablocki Veterans Administration Medical Center
Status: Active
Contact: Shelley Helen Dufek
Phone: 414-384-2000
Email: shelley.dufek@va.gov

Ontario

Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Active
Contact: Sebastien Gilbert
Email: sgilbert@toh.ca
Toronto
UHN-Toronto General Hospital
Status: Active
Contact: Gail Elizabeth Darling
Phone: 416-340-3131

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Active
Contact: Adeline Jouquan
Phone: 514-890-8000ext26214

Australia

Fitzroy
Saint Vincent's Hospital
Status: Active
Contact: Gavin Michael Wright
Email: Gavin.WRIGHT@svha.org.au

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To test the hypothesis that overall survival rate in high risk operable patients with stage I non-small cell lung cancer (NSCLC) is greater in patients who undergo stereotactic ablative radiotherapy (SAbR) as compared to standard sublobar resection (SR).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo sublobar resection.

ARM II: Patients undergo stereotactic ablative radiotherapy over approximately 60 minutes for 3 fractions within 16 days.

After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
UT Southwestern / Simmons Cancer Center-Dallas

Principal Investigator
Robert D. Timmerman

Trial IDs

Primary ID SCCC-02515; STU 022015-069
Secondary IDs NCI-2015-01676
Clinicaltrials.gov ID NCT02468024