Head and Neck CancerART in HNTNCT06214611
Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors
A study testing Adaptive Radiotherapy in people with Head and Neck Cancer and Adaptive Radiotherapy, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Adaptive Radiotherapy, Radiation
- What is being tested?
- Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2023to 15 Oct 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0-1
- Histopathology confirmation
- Compliance
- Tumor in the head and neck region
- Indication for radiotherapy
Who cannot join
- 1. Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Essen, Germany / NRW, 45147
About this study
Official title: Adaptive Radiotherapy in the Treatment of Patients With a Histologically Confirmed Malignant Tumor in the Head and Neck Region: Prospective Validation of ART in Patients With HNT (Prospektive Validierung Der ART Bei Patientinnen Und Patienen Mit Kopf-Hals Tumoren,)
Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.
Read the detailed description
The aim here is to prospectively evaluate modern technical standards. In the last 25 years, radiotherapy has developed rapidly away from two-dimensional procedures towards volume-modulated, three-dimensional techniques. But here, too, there is a broad radiotherapeutic spectrum due to the high technical diversity in radiotherapy and ever newer technical innovations. (1) Definitive radiochemotherapy is standard of care for locally advanced head and neck tumors. The aim of this study is to monitor the influence of the new technical therapy standards (therapy options in application: volume-modulated rapid-arc technique (VMAT) / online onboard image-guidance (IGRT) and adaptive re-planning, using the linear accelerator ETHOS currently established and installed at the Department of Radiotherapy in December 2021) as a function of dose parameters for quality assurance of feasibility.
Therapy with ETHOS represents a comprehensive new treatment option that is tailored and individualized from the initial planning and adjustment on the treatment table to radiation monitoring of the whole therapy.
Online-adaptive radiotherapy (ART) allows the dose distribution to be adapted to the anatomical changes online and immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard of care in radiotherapy. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations of the body from radiation fraction to radiation fraction, e.g. through different positioning of the tongue or jaw.
This trial creates the basis for standardizing treatment parameters as far as possible, but also for introducing improvements in the treatment of future patients in a personalized and individualized form.
Standard therapy can be further optimized using modern equipment and high-precision linear accelerators.
- Conditions
- Head and Neck Cancer, Adaptive Radiotherapy, Radiation, Optimized Treatment, Protection of Organs at Risk, Dysphagia Reduction
- Being tested
- Adaptive Radiotherapy
- Keywords
- Head and Neck Cancer, Adaptive Radiotherapy, Protection of organs at risk, Optimized treatment, Dysphagia reduction
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive RadiotherapyRadiation
Also called Dysphagia optimized Adaptive Radiotherapy (ART)
Adaptive Radiotherapy in the head and neck region
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Radiotherapy | Other | Adaptive Radiation Therapy Receives: Radiation: Adaptive Radiotherapy |
| Standard Treatment Arm, IGRT | Active comparator | Standard Treatment Arm, IGRT Receives: Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated dose distribution in CTV
accumulated dose distribution in the clinical target volume, EUD [Gy]
Measured: 2 weeks
Secondary outcomes (8)
dysphagia assessment scores
dysphagia assessment scores
Measured: 2 weeks to 5 years
Minimally isotropic PTV margin
Minimally isotropic PTV margin [mm]
Measured: 2 months
Progression free survival (PFS)
Progression free survival (PFS)
Measured: 2 months to 5 years
overall survival (OS)
overall survival (OS)
Measured: 2 months to 5 years
dose organs at risk (OAR)
dose organs at risk (OAR)
Measured: 2 weeks
Side effects, LENT-SOMA
LENT-SOMA criteria and score for Adverse Events (CTCAE)
Measured: 2 months to 5 years
quality of life (EORTC)
quality of life (EORTC)
Measured: 2 months to 5 years
Side effects (CTC AE)
Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 2 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Nov 2023
- Primary completion15 Dec 2025
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Guberina, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214611
- Sponsor's protocol ID
- 23-11129-BO
- Other IDs
- DRKS00033144
- Acronym
- ART in HNT
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chetty IJ, Martel MK, Jaffray DA, Benedict SH, Hahn SM, Berbeco R, Deye J, Jeraj R, Kavanagh B, Krishnan S, Lee N, Low DA, Mankoff D, Marks LB, Ollendorf D, Paganetti H, Ross B, Siochi RA, Timmerman RD, Wong JW. Technology for Innovation in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):485-92. doi: 10.1016/j.ijrobp.2015.07.007. Epub 2015 Jul 11.
PubMed 26460989
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiotherapy in the Treatment of Patients With a Histologically Confirmed Malignant Tumor in the Head and Neck Region: Prospective Validation of ART in Patients With HNT (Prospektive Validierung Der ART Bei Patientinnen Und Patienen Mit Kopf-Hals Tumoren,)
- ClinicalTrials.gov ID
- NCT06214611
- Acronym / sponsor ID
- ART in HNT / 23-11129-BO
- Conditions
- Head and Neck Cancer, Adaptive Radiotherapy, Radiation, Optimized Treatment, Protection of Organs at Risk, Dysphagia Reduction
- Keywords
- Head and Neck Cancer, Adaptive Radiotherapy, Protection of organs at risk, Optimized treatment, Dysphagia reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 19 Jan 2024 (actual)
- 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.
Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.
Detailed description
The aim here is to prospectively evaluate modern technical standards. In the last 25 years, radiotherapy has developed rapidly away from two-dimensional procedures towards volume-modulated, three-dimensional techniques. But here, too, there is a broad radiotherapeutic spectrum due to the high technical diversity in radiotherapy and ever newer technical innovations. (1) Definitive radiochemotherapy is standard of care for locally advanced head and neck tumors. The aim of this study is to monitor the influence of the new technical therapy standards (therapy options in application: volume-modulated rapid-arc technique (VMAT) / online onboard image-guidance (IGRT) and adaptive re-planning, using the linear accelerator ETHOS currently established and installed at the Department of Radiotherapy in December 2021) as a function of dose parameters for quality assurance of feasibility.
Therapy with ETHOS represents a comprehensive new treatment option that is tailored and individualized from the initial planning and adjustment on the treatment table to radiation monitoring of the whole therapy.
Online-adaptive radiotherapy (ART) allows the dose distribution to be adapted to the anatomical changes online and immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard of care in radiotherapy. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations of the body from radiation fraction to radiation fraction, e.g. through different positioning of the tongue or jaw.
This trial creates the basis for standardizing treatment parameters as far as possible, but also for introducing improvements in the treatment of future patients in a personalized and individualized form.
Standard therapy can be further optimized using modern equipment and high-precision linear accelerators.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Radiotherapy | Other | Radiation: Adaptive RadiotherapyAdaptive Radiation Therapy |
| Standard Treatment Arm, IGRT | Active comparator | Radiation: Adaptive RadiotherapyStandard Treatment Arm, IGRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG 0-1
- Histopathology confirmation
- Compliance
- Tumor in the head and neck region
- Indication for radiotherapy
Key exclusion criteria (1 listed)
- 1. 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 |
|---|---|---|
| Adaptive RadiotherapyAlso: Dysphagia optimized Adaptive Radiotherapy (ART)Adaptive Radiotherapy in the head and neck region | Radiation | Adaptive Radiotherapy, Standard Treatment Arm, IGRT |
Primary outcome
Accumulated dose distribution in CTV
Time frame: 2 weeks
accumulated dose distribution in the clinical target volume, EUD [Gy]
8 secondary outcomes
dysphagia assessment scores
Time frame: 2 weeks to 5 years
Minimally isotropic PTV margin
Time frame: 2 months
Progression free survival (PFS)
Time frame: 2 months to 5 years
overall survival (OS)
Time frame: 2 months to 5 years
dose organs at risk (OAR)
Time frame: 2 weeks
Side effects, LENT-SOMA
Time frame: 2 months to 5 years
quality of life (EORTC)
Time frame: 2 months to 5 years
Side effects (CTC AE)
Time frame: 2 months to 5 years
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 20 Oct 2026.
- Background: PubMed 26460989Chetty IJ, Martel MK, Jaffray DA, Benedict SH, Hahn SM, Berbeco R, Deye J, Jeraj R, Kavanagh B, Krishnan S, Lee N, Low DA, Mankoff D, Marks LB, Ollendorf D, Paganetti H, Ross B, Siochi RA, Timmerman RD, Wong JW. Technology for Innovation in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):485-92. doi: 10.1016/j.ijrobp.2015.07.007. Epub 2015 Jul 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Radiotherapy in people with Head and Neck Cancer and Adaptive Radiotherapy, run by University Hospital, Essen at 1 site in Germany.
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 5 inclusion and 1 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 20 Oct 2026. 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.
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?
Accumulated dose distribution in CTV (time frame: 2 weeks). 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 NCT06214611, which also lists 1 linked publication.
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 20 Oct 2026.