Skin Changes in Head and Neck Cancer During Immuno-(Chemo-) And Radiotherapy With Erbitux®
With the aim of optimizing combined treatment strategies in terms of efficacy as well as
manageable side effects, the implementation of Cetuximab an EGFR targeting antibody
demonstrated successfully a significant increase in survival times, although exhibiting an
expected increase in skin toxicities (1,2). This Phase IV trial will explore this prominent
side effect, which is due to a synergistic effect of radiodermatitis and acneiform rash, in
great detail. In addition, feasibility aspects of the complex treatment schedule in common
routine and with patients presenting an increased comorbidity rate compared to the study
population studied in the pivotal Phase III trial will be observed.
Further, peripheral blood samples of patients that consent to participate in the molecular
monitoring will be collected and their genetic, epigenetic- and transcriptional profiles
correlated with clinical outcome parameters. The goal of this translational program is to
identify and confirm novel peripheral blood based molecular predictors and surrogates of
therapy response. Tissue samples and available medical evidence of patients that consent to
participate in the assessment of the HPV status will be collected. The goal of this program
is to correlate HPV status with clinical outcome parameters.
In addition, all patients will answer Quality of Life questionnaires including the EORTC
QLQ-C30 questionnaire, the Head and Neck cancer specific module (3) and the Dermatology Life
Quality Index (DLQI).
This prospective, open, multicenter phase IV study is designed to assess the rate of
radiodermatitis in patients with LASCCHN treated with a combination of radiotherapy and the
EGFR-targeted monoclonal antibody Cetuximab.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of radiation dermatitis Grade 3/4
Criteria for Adverse Events v4.0 (CTCAE) Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-theatening consequences Grade 5: Death
2 years after LPI
Jürgen Debus, Prof. Dr. Dr
University Heidelberg, Klinik für Radioonkologie und Strahlentherapie, Im Neuenheimer Feld 400, 69120 Heidelberg