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Radiotherapy dose escalation using intensity-modulated proton therapy for non-small-cell lung cancer patients

Radiotherapy dose escalation using intensity-modulated proton therapy for non-small-cell lung cancer patients - IMPT dose escalation for NSCLC (HyDose)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57660
Enrollment
87
Registered
2024-03-05
Start date
2025-12-16
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell lung cancer

Interventions

Proton radiotherpay with a higher radiation dose to the primary lung tumour&nbsp
(radiotherapy dose escalation).

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 -Signed informed consent to participate in the Standard Follow-up Program Lung -Signed informed consent for this trial prior to registration/randomization

Exclusion criteria

Exclusion criteria: - Chemotherapy not given concurrently with radiotherapy - Upfront decision that patient does not qualify for adjuvant immunotherapy - Primary tumor overlapping at with more than 40% of the mediastinal planning  risk volume - Unable or unwilling to understand the information on trial-related topics, to  give informed consent or to fill out quality of life questionnaires

Design outcomes

Primary

MeasureTime frame
Severe (grade 3+) adverse effects in the first year after radiotherapy.

Secondary

MeasureTime frame
-Local control of the lung tumour -Progresion-free survival -Distant metastasis control -Overall survival -Grade 2+ adverse effects (i.e., requiring medication), both acute and late -Qualifying for adjuvant immunotherapy after finishing chemoradiotherapy yes/no -Quality of life -Lymphocyte counts after finishing chemoradiotherapy

Countries

Netherlands

Contacts

Public ContactA.C. Hessels

Universitair Medisch Centrum Groningen

a.c.hessels@umcg.nl0503615532

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 7, 2026