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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This trial is testing whether increasing the radiation dose using a precise technique called intensity-modulated proton therapy (IMPT) leads to better outcomes in patients with stage III non-small cell lung cancer (NSCLC) who are receiving chemotherapy and radiation together, followed by immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III NSCLC confirmed by tissue biopsy - Your treatment plan includes concurrent chemotherapy and radiation, followed by immunotherapy - Your tumor is located in a position that allows for dose escalation - You are generally fit enough to participate (WHO performance score 0-2) **You may NOT be eligible if...** - You are not receiving chemotherapy at the same time as radiation - Immunotherapy has been ruled out for you upfront - Your tumor overlaps too much with the central chest area (mediastinum) - You are unable or unwilling to complete quality-of-life questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06484491


Related Trials