RecruitingNot ApplicableNCT06484491

IMPT Dose Escalation for NSCLC (HyDose)

Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients


Sponsor

University Medical Center Groningen

Enrollment

87 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interventions

RADIATIONDose-escalated intensity-modulated proton therapy (IMPT-74)

Heterogeneous simultaneous integrated boost of 74.0 Gy (RBE) to primary tumor \>15mm away form mediastinal envelope, and 64.0 Gy (RBE) to primary tumor =\< 15mm away from mediastinal envelope. The rest of the clinical target volume, including affected lymph nodes, receives 60.0 Gy (RBE).

DRUGCisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Induction course: -Cisplatin (75 mg/m2) or carboplatin (AUC 6) + pemetrexed (500mg/m2). Concurrent chemoradiotherapy: * Weekly cisplatin (20mg/m2) + docetaxel (20mg/m2) on Mondays. * Radiotherapy will be given for 5x5 days.

DRUGImmunotherapy: adjuvant durvalumab

Adjuvant treatment will be given starting 1-6 weeks after chemoradiotherapy if no progression, good performance (PS 0-1), no other contra-indication for immunotherapy. Doses: * Start durvalumab 10 mg/kg 1x/14 days. * If possible after 2 courses switch to 1500 mg flat dose 1x/4 wk. * Continue for 12 months in total.


Locations(1)

UMCG

Groningen, Netherlands

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NCT06484491