Status:
COMPLETED
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Lead Sponsor:
Heidelberg University
Conditions:
Sinonasal Malignancies
Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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) ...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01220752
Start Date
June 17 2011
End Date
December 19 2021
Last Update
September 1 2022
Active Locations (1)
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1
Dept of Radiation Oncology, University of Heidelberg, INF 400
Heidelberg, Germany, 69120