NCT06484491Recruiting
IMPT Dose Escalation for NSCLC (HyDose)
Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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 chemotherapy and radiotherapy. The main questions it aims to answer are: * Is the risk of severe radiotherapy toxicities (requiring hospital admission) within acceptable margins ? * What is a rough estimate of the effect of the treatment under study? Compared to standard care in our clinic, all participants in this pilot trial will * Receive a higher dose of proton therapy to the tumor in the lung albeit with the same number of radiotherapy visits as the current standard treatment. * Receive two additional follow-up visits at the clinic after treatment, namely 4 and 6 weeks after finishing radiotherapy. * Two additional blood withdrawals at the last week of radiotherapy and 4 weeks after finishing radiotherapy, to measure a type of white blood cells. * Receive an extra quality of life questionnaire at the last week of radiotherapy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- Sept 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Lung cancer
- NCT number
- NCT06484491
What you commit to
- Study type: Interventional
- Planned participants: 87
- From Sept 2025 to the primary completion date, Oct 2027
- 1 site in 1 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
- Chemotherapy not given concurrently with radiotherapy
- Upfront decision that adjuvant immunotherapy is not possible
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.