Adenoid Cystic Carcinoma Clinical Trial
Official title:
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
The ACCEPT (A(denoid) c(ystic) c(arcinoma), E(rbitux, and) p(article) t(herapy))-trial is a prospective, monocentric phase I/II feasibility trial evaluating toxicity and efficacy in the combined treatment of intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost with the epidermal growth factor receptor (EGFR) antibody cetuximab. The primary objective of the study is to explore the toxicity of the combined modality regimen consisting of heavy ion therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. Secondary endpoints include local control, distant control, overall disease-free survival, overall survival
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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