Randomized study to compare the radiation exposure of the hematological system by different radiation concepts in radiotherapy of head and neck tumors with elective lymph node irradiation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034748

Enrollment

Registered

2024-07-26

Start date

2024-04-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C10 C11 C32 C13 C14

Interventions

Group 1: Radiotherapy of primary tumor and lymph node metastases plus elective lymph node irradiation in a simultaneous integrated boost concept Group 2: Early boost of 10 Gy each in 5 daily fractions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pathological evidence of laryngeal, hypopharyngeal, p16 negative oropharyngeal or oral cavity carcinoma Indication for radiotherapy provided by the tumor board Typical clinical symptoms and sufficient medical history General condition permits repeated venous blood sampling Written patient consent to participate in the study is available

Exclusion criteria

Exclusion criteria: Known genetic defects associated with a reduction in DNA repair capacity (e.g. Werner syndrome, Fanconi anemia, ataxia telangiectasia) Lack of consent Pregnancy, breastfeeding Legal guardianship in health matters by third parties Severe mental illness Exposure to ionizing radiation at least 5 days before the start of Radiotherapy

Design outcomes

Primary

Measure	Time frame
Quantification of radiation-induced DNA damage in peripheral blood lymphocytes	—

Secondary

Measure	Time frame
Determination of lymphopenia (lymphocyte count) over the therapy	—

Countries

Germany

Contacts

Public ContactSebastian Zahnreich

Universitätsmedizin Mainz

zahnreic@uni-mainz.de06131 17 2860

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026