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
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