Combined treatment of adenoid cystic carcinoma with cetuximab and IMRT plus C12 heavy ion boost: ACCEPT [ACC, Erbitux？ and particle therapy]

The ACCEPT trial is a prospective, mono-centric, phase I/II trial evaluating toxicity (primary endpoint: acute and late effects) and efficacy (secondary endpoint: local control, distant control, disease-free survival, overall survival) of the combined treatment with IMRT/carbon ion boost and weekly cetuximab in 49 patients with histologically proven (≥R1-resected, inoperable or Pn+) ACC. Patients receive 18 GyE carbon ions (6 fractions) and 54 Gy IMRT (2.0 Gy/fraction) in combination with weekly cetuximab throughout radiotherapy.The primary objective of ACCEPT is to evaluate toxicity and feasibility of cetuximab and particle therapy in adenoid cystic carcinoma.Clinical Trial Identifier: NCT 01192087EudraCT number: 2010 - 022425 - 15Adenoid cystic carcinomas are rare tumors mostly of the head and neck accounting for approximately 10-15% of malignant salivary gland tumors [1]. They are characterised by a rather slow growth pattern but also perineural spread. Standard treatment so far consists of preferably complete surgical resection followed by adjuvant irradiation in case of close margins, perineural invasion, extensive primary tumor (T3, T4) or high-grade histology [2-5].Local control in this disease could already be improved high-precision radiotherapy techniques such as stereotactic radiotherapy and/or intensity-modulated radiation therapy (IMRT), dose escalation, and high-LET RT. Treatment of large inoperable or residual tumors with IMRT resulted in increased local control as compared to conventional RT achieving progression-free survival rates of 38% at 3 years [6]. Neutron RT with a local control of 75% at 5 years, so far yielded the highest control rates in adenoid cystic carcinoma though unfortunately also accompanied by significant late toxicity [7,8].Combined IMRT and C12 heavy ion boost are able to achieve similar or superior control rates as compared to neutron RT but without increase of late toxicity and subsequent morbidity. Recent results of our own g