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Open Access Study protocol

Treatment of malignant sinonasal tumours with intensity-modulated radiotherapy (IMRT) and carbon ion boost (C12)

Alexandra D Jensen1*, Anna V Nikoghosyan1, Christine Windemuth-Kieselbach2, Jürgen Debus1 and Marc W Münter1

Author Affiliations

1 Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany

2 Alcedis GmbH, Winchester-Str. 2, 35394 Gießen, Germany

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BMC Cancer 2011, 11:190  doi:10.1186/1471-2407-11-190

Published: 22 May 2011

Abstract

Background

Most patients with cancers of the nasal cavity or paranasal sinuses are candidates of radiation therapy either due incomplete resection or technical inoperability. Local control in this disease is dose dependent but technically challenging due to close proximity of critical organs and accompanying toxicity. Modern techniques such as IMRT improve toxicity rates while local control remains unchanged. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/design

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity (primary endpoint: mucositis ≥ CTCAE°III) and efficacy (secondary endpoint: local control, disease-free and overall survival) in the combined treatment with IMRT and carbon ion boost in 30 patients with histologically proven (≥R1-resected or inoperable) adeno-/or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (50 Gy at 2.0 Gy/fraction).

Discussion

The primary objective of IMRT-HIT-SNT is to evaluate toxicity and feasibility of the proposed treatment in sinonasal malignancies.

Trial Registration

Clinical trial identifier NCT 01220752