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Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Sinonasal Malignancies:, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses

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Trial Information

Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

mucositis CTC grade 3

Outcome Description:

Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy

Outcome Time Frame:

6-8 weeks post completion of treatment

Safety Issue:

Yes

Principal Investigator

Juergen Debus, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

IMRT-HIT-SNT

NCT ID:

NCT01220752

Start Date:

November 2010

Completion Date:

November 2016

Related Keywords:

  • Sinonasal Malignancies:
  • Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
  • IMRT
  • carbon ion therapy
  • paranasal sinus
  • nasal cavity
  • adenocarcinoma
  • squamous cell carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Paranasal Sinus Neoplasms

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