What this means
This trial plans to test whether proton radiation helps patients with advanced lung cancer live longer. It has not started enrolling, so it cannot yet tell us whether proton therapy works.
Plain-English summary written by an AI model from the registry listing.
- Status
- Opening soon
- Who can join
- Ages 18 and over · 182 patients planned, not yet enrolling
- Where
- Not listed
The science
- Registered title
- Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
- Trial ID
- NCT05548504 ↗
- Phase
- PHASE 2
- Study type
- interventional
- Conditions
- Non-small Cell Lung Cancer Stage III, Radiotherapy Side Effect, Frailty
- What is tested
- Photon, Proton
- Sponsor
- Odense University Hospital
- Ages
- 18 Years to no maximum
- Dates
- First posted Sep 21, 2022 · updated Sep 21, 2022
Registry summary
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.