RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares focused, high-dose radiation with surgery to remove a small part of the lung. It tests whether radiation helps people live longer. It is for adults with stage I non-small cell lung cancer who can have surgery but face a high risk of problems from it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and able to do self-care and be up and about at least half of waking hours.
  • Have non-small cell lung cancer confirmed by a tissue sample within 180 days before study group assignment.
  • Have stage IA or certain stage IB cancer, with a tumor no larger than 4 cm on a PET or PET-CT scan taken within 180 days. Hazy-looking tumors must be at least 50% solid.
  • Have a tumor near the outer part of the lung that a chest surgeon can remove by taking out only part of a lung section.
  • Have no cancer spread to distant parts of the body. Any suspicious chest lymph nodes must test negative for cancer within 180 days.
  • Have lung function tests within 180 days before signing up. If you cannot do these tests, a study chest surgeon must document that you qualify.
  • Meet the study’s rules for high surgery risk: at least one major risk factor or two minor ones. These include poor lung function, certain heart or breathing problems, older age, or a surgeon’s judgment.
  • Be able to understand and sign the consent form. If you could become pregnant, have a negative pregnancy test before signing up.

Who can't join

  • Be pregnant or breastfeeding.
  • Have already had chemotherapy, radiation, or surgery for the lung cancer being studied.
  • Have had part of the lung removed on the same side as the current tumor.
  • Have had chest radiation on the same side that is not allowed by the study. Radiation for some other cancers may be allowed if treatment areas do not overlap; opposite-lung radiation must meet timing and overlap rules.
  • Have had another invasive cancer without being cancer-free for at least 3 years. Exceptions include non-melanoma skin cancer and cancers that have not grown beyond where they started.
  • Have a tumor near the center of the lung, a tumor that cannot be removed with the planned smaller surgery, or cancer that has spread to distant body parts.
  • Have required tissue samples, scans, or lung tests that are too old, unless the stated lung-test exception applies.
  • Not meet the study’s high-risk surgery rules, or be unable to understand or sign the consent form.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

1.0 Inclusion Criteria 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. 1.4 The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization. 1.5 Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen performed within 180 days prior to randomization (reference Appendix A \& B). Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms. 1.6 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. 1.7 Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection. 1.8 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 bronchial tree diagram below. Patients with non-peripheral (central) tumors are NOT eligible. 1.9 No evidence of distant metastases. 1.10 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). 1.11 To define eligibility of patients being at high risk for surgery, certain criteria must be met. Any one (1) of the following major criteria will define the high risk status for eligibility: Major Criteria * FEV1 ≤ 50% predicted (pre-bronchodilator value) * DLCO ≤ 50% predicted (pre-bronchodilator value) * 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. If any of the major criteria are met, the patient is eligible based on high risk for surgery and minor criteria do not need to be considered. However, if no major criteria is met, at least two (2) minor criteria being met will also define eligibility for meeting the high risk status. Any two (2) of the following minor criteria will define the high risk status for eligibility: * 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 * 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. 1.12 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 to the ipsilateral side so long as possible radiation fields would not overlap. NOTE: Radiotherapy to the contralateral lung is allowed so long as it was completed more than 3 years prior to randomization and there is no overlap of radiation fields. 1.13 Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted. 1.14 No prior lung resection on the ipsilateral side. 1.15 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. 1.16 No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers). 1.17 Ability to understand and sign a written informed consent. 2.0 Exclusion Criteria 2.1 Age \<18 2.2 ECOG/Zubrod performance status (PS) greater than 3. 2.3 Radiographic findings with ground glass opacities and less than 50% solid component will be excluded. 2.4 The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization. 2.5 Tumor \> 5 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen and/or performed greater than 180 days prior to randomization. 2.6 Lymph node biopsy greater than 180 days prior to randomization. 2.7 Thoracic surgeon confirms unable to remove tumor with sublobar resection. 2.8 Tumor located non-peripheral (central) region of lung (see bronchial tree diagram in 3.1.8). 2.9 Evidence of distant metastases. 2.10 Pulmonary function test (PFT - spirometry, DLCO, +/- arterial blood gases) greater than 180 days prior to registration. Patients physically unable to perform PFT's, such as patients with tracheotomy, that do not have written documentation from study credentialed thoracic surgeon stating eligibility. 2.11 Patients that do not meet either Major criteria or Minor criteria. 2.12 Prior intra-thoracic radiation therapy on ipsilateral side. Radiotherapy to the contralateral lung completed less than 3 years prior to randomization, with radiation field overlap. 2.13 Prior chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol. 2.14 Prior lung resection on the ipsilateral side. 2.15 Pregnant and lactating women. 2.16 Prior invasive malignancy and less than 3 years disease free prior to registration (unless non-melanoma skin cancer, in-situ cancers). 2.17 Unable to understand and/ or sign a written informed consent.

Study sites (40)

CA

CO

FL

GA

IA

KS

KY

LA

MA

MD

MI

MN

NC

NJ

NY

OH

OR

PA

RI

TN

TX

UT

VA

WA

WI