A Study Comparing Sublobar Resection versus Stereotactic Ablative Radiotherapy for Lung Cancer

Overview

About this study

The purpose of this study is to determine if Stereotactic Ablative Radiotherapy improves survival over sublobar resaction in high risk operable stage I non-small cell lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
    • Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions
  • 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 ) 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)
  • At high-risk for surgery by meeting a minimum of one major criteria or two minor criteria
  • No prior intra-thoracic radiation therapy
  • 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

Exclusion Criteria

  • Evidence of distant metastases
  • Prior intra-thoracic radiation therapy
    • 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 
  • 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)

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions