Sinonasal MalignanciesPhase 2IMRT-HIT-SNTNCT01220752

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

A Phase 2 study testing carbon ion boost in people with Sinonasal Malignancies and Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sinonasal Malignancies, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
What is being tested?: carbon ion boost
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteGermany
Study dates: 17 Jun 2011to 19 Dec 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dept of Radiation Oncology, University of Heidelberg, INF 400
Heidelberg, 69120

Other trials in Germany

About this study

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.

Read the 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.

Conditions: Sinonasal Malignancies, Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses
Being tested: carbon ion boost
Keywords: IMRT, carbon ion therapy, paranasal sinus, nasal cavity, adenocarcinoma, squamous cell carcinoma
Medical subject headings: Adenocarcinoma, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carbon ion boostRadiation
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

Study groups in NCT01220752
Study group	Role	What they receive
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. Receives: Radiation: carbon ion boost

What is being measured

The primary outcome is the main question the study is designed to answer.

mucositis CTC grade 3
Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy
Measured: 6-8 weeks post completion of treatment

Secondary outcomes (5)

local control
Measured: 2 years post completion of RT
disease-free survival
Measured: 2 years post completion of RT
overall survival
Measured: 2 years post completion of RT
acute toxicity CTC grade 1/2
Measured: within 90 days of RT
late toxicity
Measured: from 90 days to trial completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 201119 Dec 2021

First posted14 Oct 2010 (estimated)
Study start17 Jun 2011
Primary completion29 Aug 2019
Study completion19 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Sinonasal MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01220752
Sponsor's protocol ID: IMRT-HIT-SNT
Acronym: IMRT-HIT-SNT
Status last verified: Aug 2022
First submitted: 12 Oct 2010
Last updated: 1 Sep 2022
Results posted: No
Data monitoring committee: No

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. doi: 10.1111/j.1365-2273.1980.tb01647.x.
PubMed 6996871
Roush 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.
PubMed 400658
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.
PubMed 18755554
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. doi: 10.1093/annonc/mdg113.
PubMed 12598339
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. doi: 10.1002/1097-0142(20011215)92:123.0.co;2-e.
PubMed 11753979
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. doi: 10.1016/0360-3016(88)90044-2.
PubMed 3335447
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. doi: 10.1148/104.3.629. No abstract available.
PubMed 4626287
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.
PubMed 10435816
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.
PubMed 12694834
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.
PubMed 12559516
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.
PubMed 14697432
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.
PubMed 18302261
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.
PubMed 19536762
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.
PubMed 18395361
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. doi: 10.1093/jnci/92.3.205.
PubMed 10655437

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
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All Sinonasal Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)
ClinicalTrials.gov ID: NCT01220752
Acronym / sponsor ID: IMRT-HIT-SNT / IMRT-HIT-SNT
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Heidelberg UniversityUniversity, hospital or other
Study start: 17 Jun 2011 (actual)
Primary completion: 29 Aug 2019 (actual)
Study completion: 19 Dec 2021 (actual)
First posted: 14 Oct 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Methods/ design:

Study objectives:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IMRT + carbon ion boost	Experimental	Radiation: 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
carbon ion boost8 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	Radiation	IMRT + carbon ion boost

Primary outcome

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

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
Background: PubMed 6996871Muir 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.
Background: PubMed 400658Roush 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.
Background: PubMed 18755554Madani 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.
Background: PubMed 12598339Licitra 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.
Background: PubMed 11753979Dulguerov 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.
Background: PubMed 3335447Parsons 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.
Background: PubMed 4626287Shukovsky 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.
Background: PubMed 10435816Brizel 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.
Background: PubMed 12694834Huang 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.
Background: PubMed 12559516Lomax 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.
Background: PubMed 14697432Mock 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.
Background: PubMed 18302261Hoppe 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juergen Debus, MD PhD principal investigator

Heidelberg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mucositis CTC grade 3 (time frame: 6-8 weeks post completion of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220752, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.