This study protocol outlines an emulated target trial to compare stereotactic ablative radiotherapy (SABR) with video-assisted thoracoscopic surgery (VATS) lobectomy for operable, early-stage NSCLC, focusing on overall survival. SABR is proposed as an alternative for patients who cannot tolerate surgery or who refuse it.
The design aims to estimate causal effects by emulating a multicenter open-label two-arm superiority randomized trial within observational data from university hospital records linked to German cancer registry data. Key trial components are specified to reduce bias, including a predefined target trial framework and a directed acyclic graph to identify mediators and confounders.
The analysis plans to assess per-protocol and intention-to-treat effects of SABR versus VATS on survival within 3 months of diagnosis, using the difference in restricted mean survival times derived from weighted non-parametric Kaplan-Meier curves. Data are anonymised and sourced from routinely collected hospital and cancer registry records, with ethical approval obtained (Dnr 2023-112).
The protocol notes potential uncertainty inherent in observational emulation and indicates results will be disseminated via peer-reviewed publications and conferences.
BMJ Open published a clinical update in Research Highlights on 02 Apr 2026.
The item focuses on Stereotactic ablative radiotherapy versus video-assisted lobectomy for operable stage I non-small-cell lung cancer: study protocol for an emulated target trial.
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