Clinical trial · Interventional
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
NCT01220752CI-TRIAL-00060652IMRT-HIT-SNTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses | — | UNRESOLVED | — |
| Sinonasal Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon ion boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT + carbon ion boost
- description
- (8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
- interventionNames
- Radiation: carbon ion boost
Primary outcomes (1)
- measure
- mucositis CTC grade 3
- timeFrame
- 6-8 weeks post completion of treatment
- description
- Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
Secondary outcomes (5)
- measure
- local control
- timeFrame
- 2 years post completion of RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDMuir 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. doi: 10.1111/j.1365-2273.1980.tb01647.x. PMID 6996871
- BACKGROUNDRoush GC. Epidemiology of cancer of the nose and paranasal sinuses: current concepts. Head Neck Surg. 1979 Sep-Oct;2(1):3-11. doi: 10.1002/hed.2890020103. PMID 400658
- BACKGROUNDMadani 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. PMID 18755554
- BACKGROUNDLicitra 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. doi: 10.1093/annonc/mdg113. PMID 12598339
- BACKGROUNDDulguerov 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. doi: 10.1002/1097-0142(20011215)92:123.0.co;2-e. PMID 11753979
- BACKGROUNDParsons 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. doi: 10.1016/0360-3016(88)90044-2. PMID 3335447
- BACKGROUNDShukovsky 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. doi: 10.1148/104.3.629. No abstract available.