Actively Recruiting
HYpofractionated, Dose-redistributed RAdiotherapy With Protons and Photons in HNSCC
Led by Joris B.W. Elbers · Updated on 2024-02-20
100
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
J
Joris B.W. Elbers
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Radiotherapy for advanced-stage head and neck squamous cell carcinoma (HNSCC) results in an unfavorable 5-year overall survival of 40%, and there is a strong biological rationale for improving outcome by combinatorial treatment with immunotherapy. However, also immunosuppressive effects of radiotherapy have been reported and recently a randomized phase-III trial failed to show any survival benefit following the combination of a PD-L1 inhibitor with chemoradiotherapy. The hypothesis is that the combination of these individually effective treatments failed because of radiation-induced lymphodepletion and that the key therefore lies in reforming conventional radiotherapy, which typically consists of large lymphotoxic radiation fields of 35 fractions. By integrating modern radiobiology and individually established innovative radiotherapy concepts, the patient's immune system could be maximally retained. This will be achieved by 1) increasing the radiation dose per fraction so that the total number of fractions can be reduced (HYpofractionation), 2) by redistributing the radiation dose towards a higher peak dose within the tumor center and a lowered elective-field dose (Dose-redistribution) and 3) by using RAdiotherapy with protons instead of photons (HYDRA). The objectives of this study are to determine the safety of HYDRA with protons and photons by conducting two parallel phase-I trials. HYDRA's efficacy will be compared to standard of care (SOC). The immune effects of HYDRA-protons will be evaluated by longitudinal immune profiling and compared to HYDRA-photons and SOC (with protons and photons). There will be a specific focus on actionable immune targets and their temporal patterns that can be tested in future hypofractionated-immunotherapy combination trials. This trial therefore is an important step towards future personalized immuno-radiotherapy combinations with the ultimate goal to improve survival for patients with HNSCC.
CONDITIONS
Official Title
HYpofractionated, Dose-redistributed RAdiotherapy With Protons and Photons in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at time of signing informed consent
- WHO performance status 0-2
- Squamous cell carcinoma of the oropharynx, hypopharynx, or larynx confirmed by cytology or histology
- Eligible for curative proton or photon therapy based on Dutch standard care criteria
- Radiotherapy planned with or without concurrent radiosensitizer
- Ability to understand study requirements and provide written informed consent
- Written informed consent obtained
You will not qualify if you...
- Prior radiation treatment on the same target volume
- Chronic inflammatory disease or immune disorders that could affect immune profiling
- Currently receiving treatment for another malignant disease or treated for one within the past 2 years (except in situ carcinoma or basal cell carcinoma of the skin)
- Psychological, familial, sociological, or geographical factors that may interfere with study compliance
- Any serious medical condition that could affect follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GL
Actively Recruiting
Research Team
J
Joris BW Elbers, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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