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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02468024
Ethics application status
Date submitted
1/06/2015
Date registered
5/06/2015
Date last updated
13/12/2018

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 - 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).
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
progression free survival - survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
toxicity as assessed toxicity using the Common Toxicity Criteria - 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.

- 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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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United States of America
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California
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Colorado
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Georgia
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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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
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Canada
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Quebec

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

Ethics approval
Ethics application status

Summary
Brief summary
To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
Trial website
https://clinicaltrials.gov/show/NCT02468024
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
Robert Timmerman, MD
Address 0 0
Country 0 0
Phone 0 0
214-645-8525
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable