Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Heidelberg University
Collaborators:
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany Merck KGaA Merck KGaA, Darmstadt, Germany University Hospital Heidelberg