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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:12/16/2018
Start Date:July 2015
End Date:December 2024
Contact:Robert Timmerman, MD
Phone:214-645-8525

Use our guide to learn which trials are right for you!

JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial

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

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.

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.

- Biopsy confirmed non-small cell lung cancer.

- Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT
scan of the chest and upper abdomen performed within 60 days prior to registration.

- 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.

- 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 90 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 3.1.10 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

- 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 within 60 days 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).
We found this trial at
37
sites
41 Victoria Parade
Fitzroy, Victoria 3065
?
mi
from
Fitzroy,
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Annapolis, Maryland 21401
Phone: 443-481-1000
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-740-9300
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-3381
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
Phone: 719-776-2842
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-8415
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Robert Timmerman, MD
Phone: 214-645-8525
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 800-436-7936
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
La Jolla, California 92093
Phone: 858-822-6100
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lexington, Kentucky 40536
Phone: 859-323-6880
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-588-6000
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38163
Phone: 901-448-2918
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Milwaukee, Wisconsin 53295
Phone: 414-384-2000
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
1945 New Jersey 33
Neptune, New Jersey 07753
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
?
mi
from
New York, NY
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
5050 Northeast Hoyt Street
Portland, Oregon 97213
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02903
Phone: 401-444-8311
?
mi
from
Providence, RI
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84157
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Phone: 912-350-8490
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Seattle, Washington 98104
Phone: 206-215-6800
?
mi
from
Seattle, WA
Click here to add this to my saved trials
State College, Pennsylvania 16803
Phone: 814-238-8418
?
mi
from
State College, PA
Click here to add this to my saved trials
766 Irving Avenue
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials