Status:
RECRUITING
HYpofractionated, Dose-redistributed RAdiotherapy With Protons and Photons in HNSCC
Lead Sponsor:
Joris B.W. Elbers
Collaborating Sponsors:
Erasmus Medical Center
HollandPTC
Conditions:
Head and Neck Squamous Cell Carcinoma
Hypofractionation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The HYDRA dose prescriptions are, in 20 fractions (instead of the conventional 35 fractions): * Inhomogeneous focal boost on the macroscopic gross tumor volume (GTVprimary tumor and GTVnodes) on FDG-...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ≥ 18 years old at time of signing informed consent.
- WHO 0-2
- Squamous cell carcinoma of the oropharynx, hypopharynx and larynx\* proven by cytology / histology
- Patients amenable for curative intent proton therapy (by model-based selection criteria, according to the Dutch standard of care) or photon therapy.
- Radiotherapy with or without concurrent radiosensitizer.
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- Written informed consent obtained.
- Note: The HYDRA dose prescriptions should be applicable for all HNSCC patients and should therefore ideally be tested within the full range of treatment indications, e.g. multiple tumor subsites and both chemoradiotherapy and radiotherapy alone. There are several reports about acceptable acute toxicity following hypofractionated chemoradiotherapy in advanced stage HNSCC. However, concerns about late toxicity remain, especially for laryngeal carcinoma. Patients with laryngeal carcinoma are therefore initially excluded, until these patients are also considered eligible for treatment with HYDRA. The statistical considerations and interim safety analyses for this purpose and the decision-making / consultation are further described elsewhere.
- Exclusion criteria
- Patients who do not meet the inclusion criteria as specified in paragraph 4.2, and/or who meet the following additional criteria:
- Previously treated by irradiation on the same target volume
- Chronic inflammatory disease or immune disorders which, according to the principal investigator, may disturb the translational immune-read out.
- Patients currently under treatment for other malignant disease (unless in situ carcinoma or basal cell carcinoma of the skin), or treated for other malignant disease within the last 2 years.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals.
- Any other serious medical condition that could interfere with follow-up.
Exclusion
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05364411
Start Date
October 10 2022
End Date
June 1 2026
Last Update
February 20 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GL