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Open Access Study protocol

Combined treatment of malignant salivary gland tumours with intensity-modulated radiation therapy (IMRT) and carbon ions: COSMIC

Alexandra D Jensen1*, Anna 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 2010, 10:546  doi:10.1186/1471-2407-10-546

Published: 11 October 2010

Abstract

Background

Local control in malignant salivary gland tumours is dose dependent. High local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/carbon ion) therapy. Considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects.

Methods/design

The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity (primary endpoint: mucositis ≥ CTCAE°3) and efficacy (secondary endpoint: local control, disease-free survival) in the combined treatment with IMRT and carbon ion boost in 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (50 Gy at 2.0 Gy/fraction).

Discussion

The primary objective of COSMIC is to evaluate toxicity and feasibility of the proposed treatment in all salivary gland malignancies.

Trial Registration

Clinical trial identifier NCT 01154270