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

This study is currently recruiting participants.
Verified April 2013 by University of Heidelberg
Sponsor:
Collaborator:
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01220752
First received: October 12, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes

October 12, 2010
April 23, 2013
November 2010
November 2014   (final data collection date for primary outcome measure)
mucositis CTC grade 3 [ Time Frame: 6-8 weeks post completion of treatment ] [ Designated as safety issue: Yes ]
Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
Same as current
Complete list of historical versions of study NCT01220752 on ClinicalTrials.gov Archive Site
  • local control [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
  • disease-free survival [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years post completion of RT ] [ Designated as safety issue: No ]
  • acute toxicity CTC grade 1/2 [ Time Frame: within 90 days of RT ] [ Designated as safety issue: Yes ]
  • late toxicity [ Time Frame: from 90 days to trial completion ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sinonasal Malignancies:
  • Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Radiation: carbon 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
Experimental: IMRT + 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.
Intervention: Radiation: carbon ion boost

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
November 2016
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Jürgen Debus, MD PhD +49-6221-56- ext 8202 juergen.debus@med.uni-heidelberg.de
Contact: Marc W Muenter, MD +49-6221-56 ext 8202 marc.muenter@med.uni-heidelberg.de
Germany
 
NCT01220752
IMRT-HIT-SNT
No
Prof. Dr. Dr. J. Debus, Dept. of Radiation Oncology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany
University of Heidelberg
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Principal Investigator: Juergen Debus, MD PhD University of Heidelberg
University of Heidelberg
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP