Cancer of the head and neck region
Conditions
Interventions
Group 1: Adjuvant chemoradiotherapy with Boost after elective nodal irradiation (60 + 4 á 2 Gy)
Group 2: Adjuvant chemoradiotherapy with Boost prior to elective nodal irradiation (4 + 60 á 2 Gy)
Sponsors
Klinik und Poliklinik für Radioonkologie und Strahlentherapie, Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histopathological confirmation of hypopharyngeal, laryngeal, oral cavity or p16-negative oropharyngeal carcinomas - Planned for postoperative radiotherapy following tumor resection and bilateral neck dissection - Indication for adjuvant chemoradiotherapy after interdisciplinary discussion in the tumor board - Performance status allows repeated blood draws - Signed informed consent form
Exclusion criteria
Exclusion criteria: - Known genetic defects associated with reduced DNA damage repair (e.g. Werner syndrome, fanconi-anemia, ataxia teleangiectasia) - lack of consent - pregnancy. breastfeeding - legal guardionship in health matters by third party - severe mental illness - no exposures to ionizing radiation that occurred less than 5 days before the start of RTx
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of radiation induced DNA-damage using gamma-H2Ax foci as a surrogate parameter of DNA double strand breaks in peripheral lymphocytes 15 min after the first radiotherapy session and prior to the third session | — |
Secondary
| Measure | Time frame |
|---|---|
| - Quantification of instable chromosome abberations in peripheral blood lymphocytes - Measuring radiation induced cell death (apoptosis) in peripheral blood lymphocytes with AnnexinV/PI test | — |
Countries
Germany
Contacts
Public ContactHeinz Schmidberger
Klinik und Poliklinik für Radioonkologie und Strahlentherapie
Outcome results
None listed