IMPT Dose Escalation for NSCLC (HyDose)
HyDose
Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
2 other identifiers
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
January 30, 2026
December 1, 2025
2.1 years
June 17, 2024
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severe (grade 3+) adverse effects up to six months after radiotherapy
Data for assesing safety will be recorded from day 1 to 365
Secondary Outcomes (10)
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
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
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
Grade 2+ adverse effects (i.e., requiring medication), both acute and late
Data for assesing safety will be recorded from day 1 to 365
- +5 more secondary outcomes
Study Arms (1)
Arm 1 Intervention group
EXPERIMENTALDose-escalated IMPT
Interventions
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMCG
Groningen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. Wijsman, MD PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
A. Van der Wekken, MD PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
E. Korevaar, dr ir (PhD)
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
July 3, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
January 30, 2026
Record last verified: 2025-12