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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    272
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 25 July 2021
ct scan
metastasis
stereotactic body radiation therapy
cancer chemotherapy
endobronchial ultrasound
lung carcinoma

Summary

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

Description

Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched cohort studies to be effective at controlling primary early lung cancer. Recent pooled analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have shown a significantly improved 3-year survival with SABR, giving further impetus for successful completion of a randomized trial .

Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.Patients will be accrued and followed for a minimum of 2-years after treatment.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment radiation therapy, Lung Surgery, Lung Surgery
Clinical Study IdentifierNCT02468024
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

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
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 PET/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, EUS/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. 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 180 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 3.1.11 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
Major Criteria
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 40mm 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 pO2 55 mm Hg or SpO2 88%
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 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

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)
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