Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy. Hypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival. Design Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy/ 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.

NCT Number	NCT05548504
Lead Sponsor	Odense University Hospital
Conditions	Non-small Cell Lung Cancer Stage III, Radiotherapy Side Effect, Frailty
Enrollment	182 participants
Start Date	2022-10-01
Primary Completion	2025-09-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2022-09-21