JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial
University of Texas Southwestern Medical Center
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-r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureLung Surgery
Sublobar Lung Resection
- RadiationRadiation therapy
Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
Locations (50)
- UCSDLa Jolla, California
- University of Colorado/MemorialAurora, Colorado
- Penrose Cancer CenterColorado Springs, Colorado
- Boca Raton Regional HospitalBoca Raton, Florida
- Curtis and Elizabeth Anderson CancerSavannah, Georgia
- University of IowaIowa City, Iowa