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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02468024




Registration number
NCT02468024
Ethics application status
Date submitted
1/06/2015
Date registered
10/06/2015

Titles & IDs
Public title
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
Scientific 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
Secondary ID [1] 0 0
STU 022015-069
Universal Trial Number (UTN)
Trial acronym
STABLE-MATES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Lung Surgery
Treatment: Other - Radiation therapy

Active comparator: Arm 1 lung surgery - Sublobar Resection (SR)

Experimental: Arm 2 radiation therapy - Stereotactic Ablative Radiotherapy (SAbR)


Treatment: Surgery: Lung Surgery
Sublobar Lung Resection

Treatment: Other: Radiation therapy
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
overall survival
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
progression free survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
toxicity as assessed toxicity using the Common Toxicity Criteria
Timepoint [2] 0 0
3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
272
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's/Peter Mac - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
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California
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Colorado
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Florida
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Louisiana
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Maryland
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Canada
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Ontario, Canada
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Mississauga
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Canada
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Toronto
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United Kingdom
State/province [31] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Other
Name
University of Texas Southwestern Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Timmerman, MD
Address 0 0
UTSW Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Neufeld, MBA
Address 0 0
Country 0 0
Phone 0 0
214-645-8525
Fax 0 0
Email 0 0
sarah.hardee@UTSouthwestern.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02468024