Overview
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
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