Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12) (IMRT-HIT-SNT)
Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Radiation: carbon ion boost
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)|
- mucositis CTC grade 3 [ Time Frame: 6-8 weeks post completion of treatment ] [ Designated as safety issue: Yes ]Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
- local control [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
- disease-free survival [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
- acute toxicity CTC grade 1/2 [ Time Frame: within 90 days of RT ] [ Designated as safety issue: Yes ]
- late toxicity [ Time Frame: from 90 days to trial completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: IMRT + carbon ion boost
(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
Radiation: carbon ion boost
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220752
|Contact: Jürgen Debus, MD PhD||+49-6221-56- ext email@example.com|
|Contact: Marc W Muenter, MD||+49-6221-56 ext firstname.lastname@example.org|
|Dept of Radiation Oncology, University of Heidelberg, INF 400||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Alexandra D Jensen, MD, MSc +49-6221-56 ext 8202 email@example.com|
|Principal Investigator:||Juergen Debus, MD PhD||Heidelberg University|