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


abstract

BACKGROUND:

Local control in adjuvant/definitive RT of adenoid cystic carcinoma (ACC) is largely dose-dependent leading to the establishment of particle therapy in this indication. However, even modern techniques leave space for improvement of local control by intensification of local treatment. Radiation sensitization by exploitation of high EGFR-expression in ACC with the EGFR receptor antibody cetuximab seems promising.

METHODS/DESIGN:

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.

DISCUSSION:

The primary objective of ACCEPT is to evaluate toxicity and feasibility of cetuximab and particle therapy in adenoid cystic carcinoma.

TRIAL REGISTRATION:

Clinical Trial Identifier: NCT 01192087. EudraCT number: 2010 - 022425 - 15.

Related Articles
RadioImmunotherapy for adenoid cystic carcinoma: a single-institution series of combined treatment with cetuximab.
Radiat Oncol. 2010
RadioImmunotherapy for adenoid cystic carcinoma: a single-institution series of combined treatment with cetuximab.
Jensen AD, Krauss J, Weichert W, Debus J, Münter MW. Radiat Oncol. 2010 Nov 3; 5:102. Epub 2010 Nov 3.
Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518).
BMC Cancer. 2006
Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518).
Jensen AD, Münter MW, Bischoff H, Haselmann R, Timke C, Krempien R, Sterzing F, Nill S, Heeger S, Hoess A, et al. BMC Cancer. 2006 May 8; 6:122. Epub 2006 May 8.
Combined treatment of malignant salivary gland tumours with intensity-modulated radiation therapy (IMRT) and carbon ions: COSMIC.
BMC Cancer. 2010
Combined treatment of malignant salivary gland tumours with intensity-modulated radiation therapy (IMRT) and carbon ions: COSMIC.
Jensen AD, Nikoghosyan A, Windemuth-Kieselbach C, Debus J, Münter MW. BMC Cancer. 2010 Oct 11; 10:546. Epub 2010 Oct 11.
Review Cetuximab: an epidermal growth factor receptor chemeric human-murine monoclonal antibody.
Drugs Today (Barc). 2005
Review Cetuximab: an epidermal growth factor receptor chemeric human-murine monoclonal antibody.
Harding J, Burtness B. Drugs Today (Barc). 2005 Feb; 41(2):107-27.
Review The efficacy of combined treatment with cetuximab (erbitux) and radiation therapy in patients with head and neck cancer.
J BUON. 2009
Review The efficacy of combined treatment with cetuximab (erbitux) and radiation therapy in patients with head and neck cancer.
Koukourakis G, Kouloulias V, Koukourakis M, Kouvaris J, Zacharias G, Gouliamos A. J BUON. 2009 Jan-Mar; 14(1):19-25.