|Phase II||Treatment||Active||18 to 80||Other||IMRT-HIT-SNT|
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.
Further Study Information
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.
- Histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses
- Inoperable tumour or refusal to undergo surgical resection
- Macroscopic or microscopic residual tumour (R2/ R1) or
- ≥T3/T4 or
- written informed consent
- pts aged 18 - 80 years
- effective contraception for pts in childbearing age (<12 months post beginning of menopause)
- Prior radio- or chemotherapy for tumours of the head and neck
- Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
- Legal incapacity or limited legal capacity
- Positive serum/ urine beta-HCG/ pregnancy
- Drug abuse
Trial Lead Organizations/Sponsors
Heidelberg UniversityUniversitatsklinikum Heidelberg
|Juergen Debus, MD PhD||Principal Investigator|
|Jürgen Debus, MD PhD||Ph: +49-6221-56- Ext.8202|
|Alexandra D Jensen, MD, MSc||Ph: +49-6221-56 Ext.8202|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01220752
ClinicalTrials.gov processed this data on March 27, 2014
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