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Open Access Study protocol

Phase II study of induction chemotherapy with TPF followed by radioimmunotherapy with Cetuximab and intensity-modulated radiotherapy (IMRT) in combination with a carbon ion boost for locally advanced tumours of the oro-, hypopharynx and larynx - TPF-C-HIT

Alexandra D Jensen1*, Jürgen Krauss2, Karin Potthoff1, Almaz Desta3, Gregor Habl1, Athanasios Mavtratzas2, Christine Windemuth-Kiesselbach3, Jürgen Debus1 and Marc W Münter1

Author Affiliations

1 Dept. of Radiation Oncology INF 400 69120 Heidelberg Germany

2 National Centre for Tumour Diseases (NCT) INF 460 69120 Heidelberg Germany

3 Alcedis GmbH Winchester-Str. 2 35394 Gießen Germany

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BMC Cancer 2011, 11:182  doi:10.1186/1471-2407-11-182

Published: 19 May 2011

Abstract

Background

Long-term locoregional control in locally advanced squamous cell carcinoma of the head and neck (SCCHN) remains challenging. While recent years have seen various approaches to improve outcome by intensification of treatment schedules through introduction of novel induction and combination chemotherapy regimen and altered fractionation regimen, patient tolerance to higher treatment intensities is limited by accompanying side-effects. Combined radioimmunotherapy with cetuximab as well as modern radiotherapy techniques such as intensity-modulated radiotherapy (IMRT) and carbon ion therapy (C12) are able to limit toxicity while maintaining treatment effects. In order to achieve maximum efficacy with yet acceptable toxicity, this sequential phase II trial combines induction chemotherapy with docetaxel, cisplatin, and 5-FU (TPF) followed by radioimmunotherapy with cetuximab as IMRT plus carbon ion boost. We expect this approach to result in increased cure rates with yet manageable accompanying toxicity.

Methods/design

The TPF-C-HIT trial is a prospective, mono-centric, open-label, non-randomized phase II trial evaluating efficacy and toxicity of the combined treatment with IMRT/carbon ion boost and weekly cetuximab in 50 patients with histologically proven locally advanced SCCHN following TPF induction chemotherapy. Patients receive 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/fraction) in combination with weekly cetuximab throughout radiotherapy. Primary endpoint is locoregional control at 12 months, secondary endpoints are disease-free survival, progression-free survival, overall survival, acute and late radiation effects as well as any adverse events of the treatment as well as quality of life (QoL) analyses.

Discussion

The primary objective of TPF-C-HIT is to evaluate efficacy and toxicity of cetuximab in combination with combined IMRT/carbon ion therapy following TPF induction in locally advanced SCCHN.

Trial Registration

Clinical Trial Identifier: NCT01245985 (clinicaltrials.gov)

EudraCT number: 2009 - 016489- 10