Skip to content

Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors

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,)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06214611
Acronym
ART in HNT
Enrollment
50
Registered
2024-01-19
Start date
2023-11-15
Completion date
2027-12-15
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adaptive Radiotherapy, Dysphagia Reduction, Head and Neck Cancer, Optimized Treatment, Protection of Organs at Risk, Radiation

Keywords

Head and Neck Cancer, Adaptive Radiotherapy, Protection of organs at risk, Optimized treatment, Dysphagia reduction

Brief 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 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.

Interventions

RADIATIONAdaptive Radiotherapy

Adaptive Radiotherapy in the head and neck region

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ECOG 0-1 2. Histopathology confirmation 3. Compliance 4. Tumor in the head and neck region 5. Indication for radiotherapy

Exclusion criteria

1\. Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Accumulated dose distribution in CTV2 weeksaccumulated dose distribution in the clinical target volume, EUD \[Gy\]

Secondary

MeasureTime frameDescription
Minimally isotropic PTV margin2 monthsMinimally isotropic PTV margin \[mm\]
Progression free survival (PFS)2 months to 5 yearsProgression free survival (PFS)
overall survival (OS)2 months to 5 yearsoverall survival (OS)
dysphagia assessment scores2 weeks to 5 yearsdysphagia assessment scores
Side effects, LENT-SOMA2 months to 5 yearsLENT-SOMA criteria and score for Adverse Events (CTCAE)
quality of life (EORTC)2 months to 5 yearsquality of life (EORTC)
Side effects (CTC AE)2 months to 5 yearsCommon Terminology Criteria for Adverse Events (CTCAE)
dose organs at risk (OAR)2 weeksdose organs at risk (OAR)

Countries

Germany

Contacts

Primary ContactMaja PD Dr. med. Guberina, PD Dr. med. (MD), specialist
maja.guberina@uk-essen.de+492017232321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026