Sublobar Resection or Stereotactic Ablative Radiotherapy in Treating Patients with Stage I Non-small Cell Lung Cancer
- 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 of 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 90 days prior to randomization
- 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 90 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 ** DLCO =< 50% predicted * Minor criteria ** FEV1 51-60% predicted ** DLCO 51-60% predicted ** Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm 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 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 ** 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
- 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 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
I. To test the hypothesis that overall survival rate in high risk operable patients with stage I non-small cell lung cancer (NSCLC) is greater in patients who undergo stereotactic ablative radiotherapy (SAbR) as compared to standard sublobar resection (SR).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo sublobar resection.
ARM II: Patients undergo stereotactic ablative radiotherapy over approximately 60 minutes for 3 fractions within 16 days.
After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months.
Trial Phase Phase III
Trial Type Treatment
UT Southwestern / Simmons Cancer Center-Dallas
Robert D. Timmerman
- Primary ID SCCC-02515; STU 022015-069
- Secondary IDs NCI-2015-01676
- Clinicaltrials.gov ID NCT02468024