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Recruiting Phase 3 NCT02468024

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

Trial Parameters

Condition Non-Small Cell Lung Cancer
Sponsor University of Texas Southwestern Medical Center
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 272
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2015-07
Completion 2028-12
Interventions
Lung SurgeryRadiation therapy

Brief Summary

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

Eligibility Criteria

1.0 Inclusion Criteria 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater. 1.4 The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization. 1.5 Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen performed within 180 days prior to randomization (reference Appendix A \& B). Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms. 1.6 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 method

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