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 Heidelberg University
Sponsor:
Collaborator:
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01220752
First received: October 12, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Sinonasal Malignancies:
Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Radiation: carbon ion boost
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220752

Contacts
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

Locations
Germany
Dept of Radiation Oncology, University of Heidelberg, INF 400 Recruiting
Heidelberg, Germany, 69120
Contact: Alexandra D Jensen, MD, MSc    +49-6221-56 ext 8202    alexandra.jensen@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Investigators
Principal Investigator: Juergen Debus, MD PhD Heidelberg University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Dr. J. Debus, Dept. of Radiation Oncology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT01220752     History of Changes
Other Study ID Numbers: IMRT-HIT-SNT
Study First Received: October 12, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Heidelberg University:
IMRT
carbon ion therapy
paranasal sinus
nasal cavity
adenocarcinoma
squamous cell carcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Paranasal Sinus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014