Combined Treatment of Adenoid Cystic Carcinoma With Cetuximab and IMRT Plus C12 Heavy Ion Boost - ACCEPT - (ACC, Erbitux, and Particle Therapy); Phase I/II Feasibility Study
Treatment with novel radiotherapeutic technologies could increase local control in adenoid
cystic carcinoma of the head and neck. Especially combined treatment with
intensity-modulated radiation therapy and heavy ion (C12) boost to the primary tumor or
previous tumor bed could be established as the treatment of choice in this disease.
Unfortunately, therapeutic results in the treatment of adenoid cystic carcinoma are still
hampered by the occurrence of distant metastases (predominantly in the lungs) which, though
progressing comparatively slowly, still limit the patient's life expectancy. Most adenoid
cystic carcinomas (> 80%) though, exhibit over-expression of EGFR receptors and hence
provide an approach for systemic treatment. In this prospective phase II trial, the
application of the EGFR antibody cetuximab will be evaluated in combination with the
established treatment of intensity-modulated radiation therapy plus C12 heavy ion boost.
The trial aims at evaluation of toxicity and feasibility of the combined treatment, as
primary endpoint, as well as local control and disease-free survival as secondary endpoints.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with acute adverse effects as a Measure of toxicity
The primary objective is to explore the toxicity of the combined treatment consisting of heavy ion therapy / IMRT and cetuximab by assessing the rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. Acute treatment effects will be evaluated 6 weeks and late effects 3 years post completion of treatment
6 weeks post completion of therapy
Jürgen Debus, Prof. Dr. Dr.
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany