NCT05548504Not yet recruitingPhase 2
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 · Last updated 21 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 14 Feb 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Odense University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05548504
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 182
- From 1 Oct 2022 to the primary completion date, 30 Sept 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.
Other illness
- Uncontrolled other malignant disease.
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.