Histologically confirmed malignant tumor in the head and neck region: - Tumors of the aerodigestive tract (oral cavity/floor, upper/lower jaw, nasopharynx/oropharynx/hypopharynx, larynx, sinuses, nose) - Lateral tumors: salivary gland tumors - Tumors of the skin in the head and neck region
Conditions
Interventions
Group 1: 1. Retrospective cohort
Patients with histologically confirmed malignant tumors of the head and neck region who were treated between 2016 and 2025 at the University Hospital Giessen. Clinical
Sponsors
Universitätsklinikum Gießen und Marburg GmbH; Klinik für Strahlentherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically confirmed malignant tumor in the head and neck region: - Tumors of the aerodigestive tract (oral cavity/floor, upper/lower jaw, nasopharynx/oropharynx/hypopharynx, larynx, sinuses, nose) - Lateral tumors: salivary gland tumors - Tumors of the skin in the head and neck region • Age = 18 years • For prospective phase: written consent
Exclusion criteria
Exclusion criteria: • Benign tumors • Incomplete basic data (retrospective)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recording clinical courses, oncological outcomes, and functional limitations in patients with malignant tumors in the head and neck region as part of a combined retrospective and prospective registry. 2. Determination of progression-free survival (PFS), overall survival (OS), metastasis-free survival (MFS), and local control for various tumor entities, stages, and treatment concepts. 3. Documentation and analysis of therapy-associated side effects, especially in multimodal therapies (combination of radiotherapy, chemotherapy, immunotherapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. Expansion of the evidence base regarding toxicity profiles in combination therapies, particularly in relation to: - Dose–volume parameters (DVH parameters) or re-irradiation - Immunotherapy with cetuximab or immune checkpoint inhibitors (e.g., pembrolizumab) - Conventional chemotherapy 5. Identification of predictors for severe toxicities (= CTCAE grade 3), such as PEG dependency, dysphagia, xerostomia, or osteoradionecrosis. 6. Analysis and optimization of radiotherapy planning, particularly with regard to: - Dose distribution and the development of new dose constraints for organs at risk - Reduction of late toxicities through more precise treatment planning (e.g., adaptive radiotherapy) - Prospective analysis of postoperative radiation doses of 45–50.4 Gy (without boost) in previously histologically involved but ECE-negative lymph node regions, as no clear dose recommendation currently exists in international guidelines for this scenario - Evaluation of new radiotherapy techniques in routine clinical practice (e.g., active sparing of swallowing-related structures such as the pharynx and larynx) - Documentation and analysis of emerging radiotherapy techniques, such as hypofractionated regimens (44/55 Gy in 20 fractions), stereotactic radiotherapy for early-stage cT1–2 glottic carcinoma (e.g., SABR according to Sher et al., 2025), and short-course palliative radiotherapy regimens (e.g., QUAD Shot, 5 × 4 Gy every 3–4 weeks up to organ-at-risk dose tolerance), with regard to their clinical use, toxicity, and oncological effectiveness in routine care - Analysis of hypofractionated radiotherapy regimens (50–60 Gy in 10–12 fractions, twice weekly) for skin tumors in the head and neck region (cutaneous squamous cell carcinoma, cSCC), particularly in elderly patients and in combination therapy with cemiplimab 7. Differentiation between therapy-related side effects and disease progression or comorbidities during follow-up: - Differential diagnosis bet | — |
Countries
Germany
Contacts
Public ContactLinda Agolli
Universitätsklinikum Gießen-Marburg; Klinik für Strahlentherapie
Outcome results
None listed