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Open Access Highly Accessed Study protocol

Treatment of locally advanced carcinomas of head and neck with intensity-modulated radiation therapy (IMRT) in combination with cetuximab and chemotherapy: the REACH protocol

Gregor Habl1, Alexandra D Jensen1, Karin Potthoff1, Matthias Uhl1, Holger Hof1, Jacek Hajda4, Christian Simon3, Jürgen Debus1, Robert Krempien2 and Marc W Münter1*

Author Affiliations

1 Department of Radiation Oncology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany

2 Department of Radiation Oncology, Helios Klinikum Berlin Buch, Schwanenbecker Chaussee 50, 13125 Berlin, Germany

3 Department of Otorhinolaryngology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany

4 Coordination Centre for Clinical Trials (KKS) Heidelberg, University of Heidelberg, Vossstr. 2, 69120 Heidelberg, Germany

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BMC Cancer 2010, 10:651  doi:10.1186/1471-2407-10-651

Published: 26 November 2010

Abstract

Background

Primary treatment of carcinoma of the oro-/hypopharynx or larynx may consist of combined platinum-containing chemoradiotherapy. In order to improve clinical outcome (i.e. local control/overall survival), combined therapy is intensified by the addition of the EGFR inhibitor cetuximab (Erbitux®). Radiation therapy (RT) is carried out as intensity-modulated RT (IMRT) to avoid higher grade acute and late toxicity by sparing of surrounding normal tissues.

Methods/Design

The REACH study is a prospective phase II study combining chemoradiotherapy with carboplatin/5-Fluorouracil (5-FU) and the monoclonal epidermal growth factor-receptor (EGFR) antibody cetuximab (Erbitux®) as intensity-modulated radiation therapy in patients with locally advanced squamous-cell carcinomas of oropharynx, hypopharynx or larynx.

Patients receive weekly chemotherapy infusions in the 1st and 5th week of RT. Additionally, cetuximab is administered weekly throughout the treatment course. IMRT is delivered as in a classical concomitant boost concept (bid from fraction 16) to a total dose of 69,9 Gy.

Discussion

Primary endpoint of the trial is local-regional control (LRC). Disease-free survival, progression-free survival, overall survival, toxicity, proteomic and genomic analyses are secondary endpoints. The aim is to explore the efficacy as well as the safety and feasibility of this combined radioimmunchemotherapy in order to improve the outcome of patients with advanced head and neck cancer.

Trial registration

ISRCTN87356938