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

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

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. NOTE: Peripheral is defined as not
touching any surface within 2 cm of the proximal bronchial tree in all directions. See
below. Patients with non-peripheral (central) tumors are NOT eligible.

- 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 in 3.1.10 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).

- Patient at high-risk for surgery by meeting a minimum of one major criteria or two
minor criteria

- 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 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. 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.

- pregnant and lactating women

- prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration
(exceptions: non-melanoma skin cancer, in-situ cancers).

Principal Investigator

Fen Wang, MD

Study Contact

Fen Wang, MD, FWANG1@kumc.edu

Estimated Completion Date

Saturday, December 1, 2018

ClinicalTrials.gov #

NCT02468024
03/01/2018