Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Local control in sinonasal malignancies is dose dependent. However, dose escalation at
acceptable toxicity is technically demanding even with modern radiotherapy techniques.
Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher
doses at comparable or reduced side-effects.
The IMRT-HIT-SNT 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 36 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 (2.0 Gy/ fraction).
Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local
control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II
and late toxicity at 2 years post RT)are secondary endpoints.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
mucositis CTC grade 3
Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
6-8 weeks post completion of treatment
Juergen Debus, MD PhD
University of Heidelberg
Germany: Federal Office for Radiation Protection