Abstract
BackgroundMost 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/designThe 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).DiscussionThe primary objective of IMRT-HIT-SNT is to evaluate toxicity and feasibility of the proposed treatment in sinonasal malignancies.Trial RegistrationClinical trial identifier NCT 01220752
Highlights
Most patients with cancers of the nasal cavity or paranasal sinuses are candidates of radiation therapy either due incomplete resection or technical inoperability
Maximal surgical resection followed by adjuvant conventional radiotherapy leads to a local control of 59% and an overall survival of 40% at 5 years [5]
Study Characteristics Based on the fact that local control seems to be dosedependent and local failure within the high-dose area remains the predominant site of relapse [20,21], the combination of IMRT (50 Gy in 2 Gy/fraction) and C12-boost (24 GyE in 3 GyE/fraction) will be tested as to toxicity profile and efficacy
Summary
Sinonasal malignancies are a heterogeneous group of tumours of the nasal cavity and paranasal sinuses accounting for about 5% of head and neck tumours and 1% of all cancers [1,2]. Treatment concepts for these tumours remain a challenge: radiation oncologists and patients are confronted with the choice of either applying high radiation doses at the cost of significant side-effects or keeping side-effects low and risking higher rates of local relapse In this situation though, particle therapy with highly conformal dose distributions and increased biological effectiveness might be a way out of the dilemma and increase therapeutic range. In cases where additional chemotherapy is applied concomitantly, it is even more important to keep radiation-induced mucositis to a minimum to maintain compliance with the treatment regimen Both carbon ion therapy and IMRT have the potential to reduce normal tissue injury while allowing dose escalation within the tumour or prior tumour bed. The present trial (IMRT-HIT-SNT) was designed to evaluate toxicity with special focus on mucositis ≥ CTCAE°III and efficacy in combined intensity-modulated RT and carbon ion boost
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