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

Non-Small Cell Lung Cancer Clinical Trial

— STABLE-MATES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468024
• Other study ID #: STU 022015-069
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Sarah Neufeld, MBA
• Phone: 214-645-8525
• Email: sarah.hardee[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Procedure:
• Lung Surgery
Sublobar Lung Resection

Radiation:
• Radiation therapy
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions

Locations

Country	Name	City	State
Australia	St. Vincent's/Peter Mac	Fitzroy	Victoria
Canada	Lawson Health Science Center	London	Ontario, Canada
Canada	Trillium Health Partners	Mississauga
Canada	CHUM	Montréal	Quebec
Canada	Ottawa Hospital Cancer Center	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto
Canada	UHN-Toronto	Toronto	Ontario
United Kingdom	The James Cook University Hospital	Middlesbrough
United States	Luminis Health Research Institute	Annapolis	Maryland
United States	University of Colorado/Memorial	Aurora	Colorado
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Boston Medical Center	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western (University Hospitals Case Medical Center)	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	UCSD	La Jolla	California
United States	University of Kentucky Health Care	Lexington	Kentucky
United States	University of Louisville Physicians	Louisville	Kentucky
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Clement Zablocki VA Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Meridian Health System	Neptune	New Jersey
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Langone Medical Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Allegheny	Pittsburgh	Pennsylvania
United States	UPMC Health System	Pittsburgh	Pennsylvania
United States	Providence Health & Services/Oregon Clinic	Portland	Oregon
United States	Lifespan Oncology Clinical Research	Providence	Rhode Island
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Beaumont	Royal Oak	Michigan
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	Curtis and Elizabeth Anderson Cancer	Savannah	Georgia
United States	Swedish Cancer Institute	Seattle	Washington
United States	Mount Nittany	State College	Pennsylvania
United States	SUNY - Upsate Medical Centre	Syracuse	New York
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	To test the hypothesis that the 3-year overall survival in high risk operable patients with Stage I NSCLC is greater in patient who undergo SAbR as compared to standard sublobar resection (SR).	3 years
Secondary	progression free survival	survival at 5-years for Stage I NSCLC who undergo SR or SAbR.	5 years
Secondary	toxicity as assessed toxicity using the Common Toxicity Criteria	toxicity using the Common Toxicity Criteria	3 years