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Brief Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Official Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Study ID: NCT01220752
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dept of Radiation Oncology, University of Heidelberg, INF 400, Heidelberg, , Germany
Name: Juergen Debus, MD PhD
Affiliation: Heidelberg University
Role: PRINCIPAL_INVESTIGATOR