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

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

NCT ID: NCT06214611

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

Conditions: Official terms:
Head and Neck Neoplasms
Deglutition Disorders

Conditions: Keywords:
Head and Neck Cancer
Adaptive Radiotherapy
Protection of organs at risk
Optimized treatment
Dysphagia reduction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Adaptive Radiotherapy
Description: Adaptive Radiotherapy in the head and neck region
Arm group label: Adaptive Radiotherapy
Arm group label: Standard Treatment Arm, IGRT

Other name: Dysphagia optimized Adaptive Radiotherapy (ART)

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West

Address:
City: Essen
Zip: 45147
Country: Germany

Status: Recruiting

Contact:
Last name: Maja Guberina, PD Dr. med. (MD), specialist

Phone: +492017232321
Email: maja.guberina@uk-essen.de

Contact backup:
Last name: Ina Grübel

Investigator:
Last name: Maja Guberina, PD Dr. med. (MD)
Email: Principal Investigator

Start date: November 15, 2023

Completion date: December 15, 2027

Lead sponsor:
Agency: University Hospital, Essen
Agency class: Other

Source: University Hospital, Essen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06214611