Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC
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 in the
combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12)
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 (2.0 Gy/
fraction).
Study objectives:
Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local
control, disease-free survival, toxicity (incl. mucositis CTC °I-II and late toxicity at 3
years post RT)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
mucositis ≥ CTC°3
6-8 weeks post completion of treatment
Yes
Marc W Muenter, MD
Principal Investigator
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg
Germany: "Bundesamt für Strahlenschutz" (German Radiation Protection Authority)
COSMIC
NCT01154270
June 2010
September 2013
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