HYpofractionated, Dose-redistributed RAdiotherapy with protons and photons to combat radiation-induced immunosuppression in head and neck squamous cell carcinoma
Recruiting
- Conditions
- Head and neck squamous cell carcinoma10027655
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx
who are eligible for curative intent proton or photon therapy, with or without
concurrent radiosensitizer
Exclusion Criteria
• Previously treated by irradiation in the head and neck region
• Chronic inflammatory disease or immune disorders
• Other malignant disease (unless in situ carcinoma or BCC) within the last 2
years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety of HYDRA-protons and HYDRA-photons in terms of radiation-induced grade<br /><br>3-4 late toxicity, physician-reported by CTCAE v5.0, monitored until 1 year<br /><br>after the last patient has completed HYDRA. HYDRA is randomized with standard<br /><br>of care for translational research purposes; a direct comparison of toxicity<br /><br>will statistically not be conclusive and is outside the scope of this study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Objective response rate 3 months after HYDRA (group 1 and 3), defined by<br /><br>radiological response on CT-scans or MRI using RECIST version 1.1 and/or<br /><br>histopathological confirmation of residual disease, in comparison to standard<br /><br>of care (group 2 and 4, respectively).<br /><br>• Efficacy of HYDRA (group 1 and 3) in terms of in-field and nodal elective<br /><br>field tumor control, 1 year after the last patient is included, in comparison<br /><br>to group 2 and 4, respectively.<br /><br>• Numbers and phenotype of peripheral immune cell populations in blood and<br /><br>tissue at baseline, related to patient- and tumor characteristics (tumor<br /><br>localization, TNM status, tumor subtype, comorbidities etc.), in group 1-4.<br /><br>• Temporal changes of immune markers obtained in blood during/after treatment<br /><br>at 6 timepoints as specified in Figure 1, and differences in these changes<br /><br>between group 1-4. </p><br>