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

University Medical Center Groningen1 site in 1 country87 target enrollmentSeptember 1, 2025

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsDose-escalated intensity-modulated proton therapy (IMPT-74)Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy Immunotherapy: adjuvant durvalumab

Overview

Phase: Not Applicable
Intervention: Dose-escalated intensity-modulated proton therapy (IMPT-74)
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: University Medical Center Groningen
Enrollment: 87
Locations: 1
Primary Endpoint: Severe (grade 3+) adverse effects up to six months after radiotherapy
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2025

End Date

October 1, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Medical Center Groningen

Responsible Party

Sponsor

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

Arms & Interventions

Arm 1 Intervention group

Dose-escalated IMPT

Intervention: Dose-escalated intensity-modulated proton therapy (IMPT-74)

Arm 1 Intervention group

Dose-escalated IMPT

Intervention: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

Arm 1 Intervention group

Dose-escalated IMPT

Intervention: Immunotherapy: adjuvant durvalumab

Outcomes

Primary Outcomes

Severe (grade 3+) adverse effects up to six months after radiotherapy

Time Frame: Data for assesing safety will be recorded from day 1 to 365

Secondary Outcomes

European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30)(Data for assesing quality of life will be recorded up to day 730)
Grade 2+ adverse effects (i.e., requiring medication), both acute and late(Data for assesing safety will be recorded from day 1 to 365)
Local control of the lung tumour assessed by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Data for assessing local control will be recorded up to 2 years after chemoradiotherapy)
Distant metastasis control based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Data for assessing distant metastasis will be recorded up to 2 years after chemoradiotherapy)
Overall survival(Data for assessing overall survival will be recorded up to 2 years after chemoradiotherapy)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13-item (EORTC-QLQ-LC13)(Data for assesing quality of life will be recorded up to day 730)
3 EuroQoL-5D three-level version (EQ-5D-3L)(Data for assesing quality of life will be recorded up to day 730)
Progression-free survival based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Data for assessing progression-free survival will be recorded up to 2 years after chemoradiotherapy)
Qualifying for adjuvant immunotherapy after finishing chemoradiotherapy yes/no(Data on qualifying for adjuvant immunotherapy will be recorded up to 6 weeks after finishing chemoradiotherapy)
Lymphocyte counts after finishing chemoradiotherapy(Data for assessing lymphocyte counts will be assessed between 4 and 6 weeks after chemoradiotherapy)