The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.
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. Methods/ design: 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). Study objectives: 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks
Dept of Radiation Oncology, University of Heidelberg, INF 400
Heidelberg, Germany
mucositis CTC grade 3
Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
Time frame: 6-8 weeks post completion of treatment
local control
Time frame: 2 years post completion of RT
disease-free survival
Time frame: 2 years post completion of RT
overall survival
Time frame: 2 years post completion of RT
acute toxicity CTC grade 1/2
Time frame: within 90 days of RT
late toxicity
Time frame: from 90 days to trial completion
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