Sublobar Resection or Stereotactic Ablative Radiotherapy in Treating Patients with Stage I Non-small Cell Lung Cancer, The STABLE-MATES Trial

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG)/Zubrod 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 positron emission therapy (PET)/computed tomography (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, endoscopic ultrasound (EUS)/endobronchial ultrasound (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; patients with non-peripheral (central) tumors are NOT eligible
• No evidence of distant metastases
• Availability of pulmonary function tests (PFTs – spirometry, diffusing capacity of the lungs for carbon monoxide [DLCO], +/- arterial blood gases) within 180 days prior to registration; patients with tracheotomy, etc, who are physically unable to perform PFTs 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 as described below: * Major criteria ** Forced expiratory volume in 1 second (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 40 mm 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 partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88% ** Partial pressure of carbon dioxide (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 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
• Previous chemotherapy, radiotherapy, 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 sign a written informed consent