Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses, Sinonasal Malignancies
Conditions
Keywords
IMRT, carbon ion therapy, paranasal sinus, nasal cavity, adenocarcinoma, squamous cell carcinoma
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.
Interventions
RADIATIONcarbon 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
Sponsors
Heidelberg University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| overall survival | 2 years post completion of RT |
| acute toxicity CTC grade 1/2 | within 90 days of RT |
| late toxicity | from 90 days to trial completion |
| local control | 2 years post completion of RT |
| disease-free survival | 2 years post completion of RT |
Countries
Germany
Outcome results
None listed