Trial Title:
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
NCT ID:
NCT02468024
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Surgery versus SAbR
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Lung Surgery
Description:
Sublobar Lung Resection
Arm group label:
Arm 1 lung surgery
Other name:
SR
Intervention type:
Radiation
Intervention name:
Radiation therapy
Description:
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
Arm group label:
Arm 2 radiation therapy
Other name:
SAbR
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCSD
Address:
City:
La Jolla
Zip:
92023
Country:
United States
Status:
Completed
Facility:
Name:
University of Colorado/Memorial
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Completed
Facility:
Name:
Penrose Cancer Center
Address:
City:
Colorado Springs
Zip:
80907
Country:
United States
Status:
Completed
Facility:
Name:
Boca Raton Regional Hospital
Address:
City:
Boca Raton
Zip:
33486
Country:
United States
Status:
Completed
Facility:
Name:
Curtis and Elizabeth Anderson Cancer
Address:
City:
Savannah
Zip:
31404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aaron Pederson, MD
Phone:
912-350-8490
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Terminated
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Kentucky Health Care
Address:
City:
Lexington
Zip:
40536-0093
Country:
United States
Status:
Completed
Facility:
Name:
University of Louisville Physicians
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Ochsner Medical Center
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Completed
Facility:
Name:
Luminis Health Research Institute
Address:
City:
Annapolis
Zip:
21401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Young, MD
Phone:
443-481-1000
Facility:
Name:
University of Maryland Medical Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Completed
Facility:
Name:
Boston Medical Center
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Completed
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202-2689
Country:
United States
Status:
Completed
Facility:
Name:
Beaumont
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Completed
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Completed
Facility:
Name:
Meridian Health System
Address:
City:
Neptune
Zip:
07753
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas Bauer, MD
Email:
thomas.bauer@hackensackmeridian.org
Facility:
Name:
New York University Langone Medical Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
SUNY - Upsate Medical Centre
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeffrey Bogart, MD
Email:
BogartJ@upstate.edu
Contact backup:
Last name:
Erin Bingham
Email:
BinghamE@upstate.edu
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Completed
Facility:
Name:
Wake Forest Baptist Health
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Completed
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Completed
Facility:
Name:
Case Western (University Hospitals Case Medical Center)
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Merritt, MD
Phone:
614-293-8415
Email:
Robert.Meritt@osumc.edu
Facility:
Name:
Providence Health & Services/Oregon Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Completed
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Completed
Facility:
Name:
UPMC Health System
Address:
City:
Pittsburgh
Zip:
15234
Country:
United States
Status:
Completed
Facility:
Name:
Allegheny
Address:
City:
Pittsburg
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benny Weksler, MD
Email:
Benny.Weksler@AHN.org
Facility:
Name:
Mount Nittany
Address:
City:
State College
Zip:
16803
Country:
United States
Status:
Completed
Facility:
Name:
Lifespan Oncology Clinical Research
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas DiPetrillo, MD
Phone:
401-444-8311
Facility:
Name:
University of Tennessee Health Science Center
Address:
City:
Memphis
Zip:
38163
Country:
United States
Status:
Completed
Facility:
Name:
Cardiothoracic and Vascular Surgeons
Address:
City:
Austin
Zip:
78756
Country:
United States
Status:
Completed
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Timmerman, MD
Phone:
214-645-8525
Contact backup:
Last name:
Robert Timmerman, MD
Facility:
Name:
Intermountain Medical Center
Address:
City:
Salt Lake City
Zip:
84107
Country:
United States
Status:
Completed
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22901
Country:
United States
Status:
Completed
Facility:
Name:
Inova Fairfax Medical Campus
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Status:
Completed
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Louie, MD
Phone:
206-215-6800
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Clement Zablocki VA Medical Center
Address:
City:
Milwaukee
Zip:
53295
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Gore, MD
Phone:
414-384-2000
Contact backup:
Last name:
Shelly Dufek
Phone:
414-384-2000
Email:
Shelley.Dufek@va.gov
Facility:
Name:
St. Vincent's/Peter Mac
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gavin Wright, MD
Email:
Gavin.WRIGHT@svha.org.au
Contact backup:
Last name:
Laura Castleden
Email:
laura.castleden@svha.org.au
Facility:
Name:
Lawson Health Science Center
Address:
City:
London
Zip:
N6C 2R5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Richard Malthaner
Phone:
519-646-6005
Contact backup:
Last name:
Deb Lewis
Phone:
519-646-6005
Facility:
Name:
Ottawa Hospital Cancer Center
Address:
City:
Ottawa
Zip:
KIH8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Sebastien Gilbert, MD
Email:
sgilbert@toh.ca
Contact backup:
Last name:
Anna Fazekas
Email:
afazekas@toh.ca
Facility:
Name:
UHN-Toronto
Address:
City:
Toronto
Zip:
M5G2C4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Andrew Pierre, MD
Phone:
416-340-3131
Contact backup:
Last name:
Jennifer Lister
Phone:
416-340-3131
Facility:
Name:
CHUM
Address:
City:
Montréal
Zip:
26214
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Moishe Liberman, MD
Phone:
514 890-8000
Contact backup:
Last name:
Adeline Jouquan
Phone:
514 890-8000
Facility:
Name:
Trillium Health Partners
Address:
City:
Mississauga
Zip:
L5M 2N1
Country:
Canada
Status:
Completed
Facility:
Name:
Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Completed
Facility:
Name:
The James Cook University Hospital
Address:
City:
Middlesbrough
Zip:
TS4 2BW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Joel Dunning, MD
Email:
joeldunning@nhs.net
Contact backup:
Last name:
Charlotte Jacobs
Phone:
01642854974
Phone ext:
54974
Email:
charlotte.jacobs@nhs.net
Start date:
July 2015
Completion date:
December 2028
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02468024
