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

NCT01220752 | Completed Phase 2

• 1 other identifier: IMRT-HIT-SNT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• mucositis CTC grade 3

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

  6-8 weeks post completion of treatment

Secondary Outcomes (5)

• local control

  2 years post completion of RT

• disease-free survival

  2 years post completion of RT

• overall survival

  2 years post completion of RT

• acute toxicity CTC grade 1/2

  within 90 days of RT

• late toxicity

  from 90 days to trial completion

Study Arms (1)

IMRT + carbon ion boost

EXPERIMENTAL

(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

Interventions

carbon ion boost RADIATION

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

IMRT + carbon ion boost

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Dept of Radiation Oncology, University of Heidelberg, INF 400

Heidelberg, 69120, Germany

Location

Related Publications (16)

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  PMID: 11753979 BACKGROUND

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• 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. doi: 10.1016/s0167-8140(99)00043-2.

  PMID: 10435816 BACKGROUND

• 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. doi: 10.1016/s0360-3016(03)00080-4.

  PMID: 12694834 BACKGROUND

• 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. doi: 10.1016/s0167-8140(02)00308-0.

  PMID: 12559516 BACKGROUND

• Mock U, Georg D, Bogner J, Auberger T, Potter 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. doi: 10.1016/s0360-3016(03)01452-4.

  PMID: 14697432 BACKGROUND

• 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.

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  PMID: 10655437 BACKGROUND

• Jensen AD, Nikoghosyan AV, Windemuth-Kieselbach C, Debus J, Munter MW. Treatment of malignant sinonasal tumours with intensity-modulated radiotherapy (IMRT) and carbon ion boost (C12). BMC Cancer. 2011 May 22;11:190. doi: 10.1186/1471-2407-11-190.

  PMID: 21600049 DERIVED

MeSH Terms

Conditions

Adenocarcinoma; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Juergen Debus, MD PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: June 17, 2011
• Primary Completion: August 29, 2019
• Study Completion: December 19, 2021
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

DE (1)