NCT06484491 IMPT Dose Escalation for NSCLC (HyDose)
| NCT ID | NCT06484491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 87 participants in total. It began in 2025-09-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
R. Wijsman, MD PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06484491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06484491 currently recruiting?
Yes, NCT06484491 is actively recruiting participants. Contact the research team at a.c.hessels@umcg.nl for enrollment information.
Where is the NCT06484491 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06484491 clinical trial?
NCT06484491 is sponsored by University Medical Center Groningen. The principal investigator is R. Wijsman, MD PhD at University Medical Center Groningen. The trial plans to enroll 87 participants.