Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12) (IMRT-HIT-SNT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01220752|
Recruitment Status : Unknown
Verified April 2013 by Heidelberg University.
Recruitment status was: Recruiting
First Posted : October 14, 2010
Last Update Posted : April 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sinonasal Malignancies: Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses||Radiation: carbon ion boost||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2016|
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
- mucositis CTC grade 3 [ Time Frame: 6-8 weeks post completion of treatment ]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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|