Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC
HERAN2
HERAN2 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC A Randomised Multicentre Phase II Feasibility Study
1 other identifier
interventional
182
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
ExpectedSeptember 21, 2022
September 1, 2022
3 years
February 14, 2022
September 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS at 12 months after randomization
Overall survival 12 months after randomization
12 month after patient randomization
Secondary Outcomes (9)
Acute toxicity
9 months after patient randomization
Late toxicity
Up to 5 years after patient randomization
Progression free survival
up to 5 years after patient randomization
Pattern of faillure
up to 5 years after patient randomization
Changes in level of cardiac biomarkers (BNP)
12 month after patient randomization
- +4 more secondary outcomes
Study Arms (2)
Photon therapy
ACTIVE COMPARATOR50-66Gy/ 24 fractions, inhomogeneous dose distribution Photon therapy
Proton therapy
EXPERIMENTAL50-66Gy/ 24 fractions, inhomogeneous dose distribution Proton therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.
- Uncontrolled other malignant disease.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tine Schytte, PhD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Consultant
Study Record Dates
First Submitted
February 14, 2022
First Posted
September 21, 2022
Study Start
October 1, 2022
Primary Completion
September 30, 2025
Study Completion (Estimated)
September 30, 2029
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share