The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care. Potential biomarkers from a previous retrospective study will be validated in this prospective study.
Objectives: Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy. Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer. Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based. The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.
Study Type
OBSERVATIONAL
Enrollment
588
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
Prof. Anca-Ligia Grosu
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Prof. Jürgen Debus
Heidelberg, Baden-Wurttemberg, Germany
Prof. Daniel Zips
Tübingen, Baden-Wurttemberg, Germany
local recurrence free survival
Time frame: after 2 years
disease-free survival
Time frame: after 2 years
metastases-free survival
Time frame: after 2 years
overall survival
Time frame: after 2 years
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Prof. Claus Belka
München, Bavaria, Germany
Prof. Stephanie Combs
München, Bavaria, Germany
Prof. Claus Rödel
Frankfurt am Main, Hesse, Germany
Prof. Martin Stuschke
Essen, North Rhine-Westphalia, Germany
Prof. Mechthild Krause
Dresden, Saxony, Germany
Prof. Volker Budach
Berlin, Germany
Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
Dresden, Germany