127TiP Phase I study of neo-adjuvant Stereotactic Body Radiotherapy (SBRT) in operable patients with borderline resectable locally advanced NSCLC (LA-NSCLC) (LINNEARRE I STUDY: NCT02433574)

Background: Patients with NSCLC who undergo incomplete resection (R1) have significantly worse survival compared to those with complete resection (R0). The efficacy of Stereotactic Body Radiotherapy (SBRT) in treating small lung tumors is established, but its use as neo-adjuvant therapy in locally-advanced (LA)-NSCLC is not investigated. We hypothesized that pre-operative SBRT can be done safely and could improve rates of R0 resection in LA-NSCLC. This concept could introduce a rapid, convenient and less toxic neoadjuvant therapy in LA-NSCLC to help improve rates of complete resection. LINNEARRE I is single institution phase I study that investigates the safety and feasibility of delivering, timely, neo-adjuvant hypo-fractionated RT of escalating Biological Equivalent Doses (BED) approaching those of SBRT. Trial design: A total of twenty patients with biopsy proven T3-T4, N0-1, M0, NSCLC will be enrolled. Patients must be deemed as medically operable, by a thoracic surgeon, but at risk of