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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220752
First Posted: October 14, 2010
Last Update Posted: April 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Information provided by:
Heidelberg University
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • mucositis CTC grade 3 [ Time Frame: 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 Outcome Measures:
  • local control [ Time Frame: 2 years post completion of RT ]
  • disease-free survival [ Time Frame: 2 years post completion of RT ]
  • overall survival [ Time Frame: 2 years post completion of RT ]
  • acute toxicity CTC grade 1/2 [ Time Frame: within 90 days of RT ]
  • late toxicity [ Time Frame: from 90 days to trial completion ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Muir CS, Nectoux J. Descriptive epidemiology of malignant neoplasms of nose, nasal cavities, middle ear and accessory sinuses. Clin Otolaryngol Allied Sci. 1980 Jun;5(3):195-211. Review.
Roush GC. Epidemiology of cancer of the nose and paranasal sinuses: current concepts. Head Neck Surg. 1979 Sep-Oct;2(1):3-11. Review.
Madani I, Bonte K, Vakaet L, Boterberg T, De Neve W. Intensity-modulated radiotherapy for sinonasal tumors: Ghent University Hospital update. Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):424-32. doi: 10.1016/j.ijrobp.2008.04.037. Epub 2008 Aug 26.
Licitra L, Locati LD, Cavina R, Garassino I, Mattavelli F, Pizzi N, Quattrone P, Valagussa P, Gianni L, Bonadonna G, Solero CL, Cantu G. Primary chemotherapy followed by anterior craniofacial resection and radiotherapy for paranasal cancer. Ann Oncol. 2003 Mar;14(3):367-72.
Dulguerov P, Jacobsen MS, Allal AS, Lehmann W, Calcaterra T. Nasal and paranasal sinus carcinoma: are we making progress? A series of 220 patients and a systematic review. Cancer. 2001 Dec 15;92(12):3012-29.
Parsons JT, Mendenhall WM, Mancuso AA, Cassisi NJ, Million RR. Malignant tumors of the nasal cavity and ethmoid and sphenoid sinuses. Int J Radiat Oncol Biol Phys. 1988 Jan;14(1):11-22.
Shukovsky LJ, Fletcher GH. Retinal and optic nerve complications in a high dose irradiation technique of ethmoid sinus and nasal cavity. Radiology. 1972 Sep;104(3):629-34.
Brizel DM, Light K, Zhou SM, Marks LB. Conformal radiation therapy treatment planning reduces the dose to the optic structures for patients with tumors of the paranasal sinuses. Radiother Oncol. 1999 Jun;51(3):215-8.
Huang D, Xia P, Akazawa P, Akazawa C, Quivey JM, Verhey LJ, Kaplan M, Lee N. Comparison of treatment plans using intensity-modulated radiotherapy and three-dimensional conformal radiotherapy for paranasal sinus carcinoma. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):158-68.
Lomax AJ, Goitein M, Adams J. Intensity modulation in radiotherapy: photons versus protons in the paranasal sinus. Radiother Oncol. 2003 Jan;66(1):11-8.
Mock U, Georg D, Bogner J, Auberger T, Pötter R. Treatment planning comparison of conventional, 3D conformal, and intensity-modulated photon (IMRT) and proton therapy for paranasal sinus carcinoma. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):147-54.
Hoppe BS, Wolden SL, Zelefsky MJ, Mechalakos JG, Shah JP, Kraus DH, Lee N. Postoperative intensity-modulated radiation therapy for cancers of the paranasal sinuses, nasal cavity, and lacrimal glands: technique, early outcomes, and toxicity. Head Neck. 2008 Jul;30(7):925-32. doi: 10.1002/hed.20800.
Truong MT, Kamat UR, Liebsch NJ, Curry WT, Lin DT, Barker FG 2nd, Loeffler JS, Chan AW. Proton radiation therapy for primary sphenoid sinus malignancies: treatment outcome and prognostic factors. Head Neck. 2009 Oct;31(10):1297-308. doi: 10.1002/hed.21092.
Hoppe BS, Nelson CJ, Gomez DR, Stegman LD, Wu AJ, Wolden SL, Pfister DG, Zelefsky MJ, Shah JP, Kraus DH, Lee NY. Unresectable carcinoma of the paranasal sinuses: outcomes and toxicities. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):763-9. doi: 10.1016/j.ijrobp.2008.01.038. Epub 2008 Apr 18.
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

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
First Submitted: October 12, 2010
First Posted: October 14, 2010
Last Update Posted: April 24, 2013
Last Verified: April 2013

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

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


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