Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
- Conditions
- Sinonasal MalignanciesAdenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
- Interventions
- Radiation: carbon ion boost
- Registration Number
- NCT01220752
- Lead Sponsor
- Heidelberg University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMRT + carbon ion boost 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.
- Primary Outcome Measures
Name Time Method mucositis CTC grade 3 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
- Secondary Outcome Measures
Name Time Method overall survival 2 years post completion of RT acute toxicity CTC grade 1/2 within 90 days of RT local control 2 years post completion of RT late toxicity from 90 days to trial completion disease-free survival 2 years post completion of RT
Trial Locations
- Locations (1)
Dept of Radiation Oncology, University of Heidelberg, INF 400
🇩🇪Heidelberg, Germany