Status:
NOT_YET_RECRUITING
IMPT Dose Escalation for NSCLC (HyDose)
Lead Sponsor:
University Medical Center Groningen
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical pilot trial is to learn if dose to the tumor in the lung can be safely increased using proton therapy in stage III non-small-cell lung cancer patients receiving combined chem...
Eligibility Criteria
Inclusion
- Age ≥18 years
- WHO performance score 0-2
- Histologically proven stage III NSCLC
- Planned for CCRT and adjuvant immunotherapy (intention to treat)
- Primary tumour volume outside of mediastinal PRV (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation
Exclusion
- Chemotherapy not given concurrently with radiotherapy
- Upfront decision that adjuvant immunotherapy is not possible
- Primary tumour overlapping ≥40% with mediastinal PRV
- Unable or unwilling to understand the information on trial-related topics, to give informed consent or to fill out quality-of-life questionnaires
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06484491
Start Date
September 1 2025
End Date
October 1 2028
Last Update
August 21 2025
Active Locations (1)
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1
UMCG
Groningen, Netherlands