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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-006283
    NCT ID: NCT02468024
    Sponsor Protocol Number: STU 022015-069

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

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CLS-20267558

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