Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Histological or cytological confirmed LA_NSCLC
Not candidate for definitive chemo-radiotherapy
Performance status 0-2
Signed informed consent
Disqualifiers
Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.
Uncontrolled other malignant disease.
Pregnancy
Trial design
Treatments tested in this trial
- Photon
- Proton
Treatment groups
182 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov