Clinical trial NCT01220752: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Official title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sinonasal Malignancies
Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Keywords: IMRT
carbon ion therapy
paranasal sinus
nasal cavity
adenocarcinoma
squamous cell carcinoma
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mucositis CTC grade 3
timeFrame: 6-8 weeks post completion of treatment
Secondary outcomes:
measure: local control
timeFrame: 2 years post completion of RT
measure: disease-free survival
timeFrame: 2 years post completion of RT
measure: overall survival
timeFrame: 2 years post completion of RT
measure: acute toxicity CTC grade 1/2
timeFrame: within 90 days of RT
measure: late toxicity
timeFrame: from 90 days to trial completion
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dept of Radiation Oncology, University of Heidelberg, INF 400
Study officials:
affiliation: Heidelberg University
name: Juergen Debus, MD PhD
role: PRINCIPAL_INVESTIGATOR
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