Clinical trial NCT06214611: Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors
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,)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Accumulated dose distribution in CTV
timeFrame: 2 weeks
Secondary outcomes:
measure: dysphagia assessment scores
timeFrame: 2 weeks to 5 years
measure: Minimally isotropic PTV margin
timeFrame: 2 months
measure: Progression free survival (PFS)
timeFrame: 2 months to 5 years
measure: overall survival (OS)
timeFrame: 2 months to 5 years
measure: dose organs at risk (OAR)
timeFrame: 2 weeks
measure: Side effects, LENT-SOMA
timeFrame: 2 months to 5 years
measure: quality of life (EORTC)
timeFrame: 2 months to 5 years
measure: Side effects (CTC AE)
timeFrame: 2 months to 5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
state: Germany / NRW
Study officials:
References:
citation: 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.