Clinical trial · Interventional
Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
HERAN2 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC A Randomised Multicentre Phase II Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frailty | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon | Radiation | — | UNRESOLVED |
| Proton | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Photon therapy
- description
- 50-66Gy/ 24 fractions, inhomogeneous dose distribution Photon therapy
- interventionNames
- Radiation: Photon
- type
- EXPERIMENTAL
- label
- Proton therapy
- description
- 50-66Gy/ 24 fractions, inhomogeneous dose distribution Proton therapy
- interventionNames
- Radiation: Proton
Primary outcomes (1)
- measure
- OS at 12 months after randomization
- timeFrame
- 12 month after patient randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmed LA\_NSCLC * Not candidate for definitive chemo-radiotherapy * Performance status 0-2 * Signed informed consent * Able to comply with study and follow-up procedures Exclusion Criteria: * Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields. * Uncontrolled other malignant disease. * Pregnancy
References
Publications (0)
Data not yet available