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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06214611

Studienbeginn:
November 2023

Letztes Update:
24.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms, Deglutition Disorders

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Kontakt

Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist
Kontakt:
Phone: +492017232321
E-Mail: maja.guberina@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maja Guberina, PD Dr. med. (MD), specialist
Phone: +492017232321
E-Mail: maja.guberina@uk-essen.de

Ina Grübel» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Accumulated dose distribution in CTV (Time Frame - 2 weeks):
accumulated dose distribution in the clinical target volume, EUD [Gy]

Secondary outcome:

1. dysphagia assessment scores (Time Frame - 2 weeks to 5 years):
dysphagia assessment scores

2. Minimally isotropic PTV margin (Time Frame - 2 months):
Minimally isotropic PTV margin [mm]

3. Progression free survival (PFS) (Time Frame - 2 months to 5 years):
Progression free survival (PFS)

4. overall survival (OS) (Time Frame - 2 months to 5 years):
overall survival (OS)

5. dose organs at risk (OAR) (Time Frame - 2 weeks):
dose organs at risk (OAR)

6. Side effects, LENT-SOMA (Time Frame - 2 months to 5 years):
LENT-SOMA criteria and score for Adverse Events (CTCAE)

7. quality of life (EORTC) (Time Frame - 2 months to 5 years):
quality of life (EORTC)

8. Side effects (CTC AE) (Time Frame - 2 months to 5 years):
Common Terminology Criteria for Adverse Events (CTCAE)

Studien-Arme

Other: Adaptive Radiotherapy
Adaptive Radiation Therapy
Active Comparator: Standard Treatment Arm, IGRT
Standard Treatment Arm, IGRT

Geprüfte Regime

Adaptive Radiotherapy (Dysphagia optimized Adaptive Radiotherapy (ART)):
Adaptive Radiotherapy in the head and neck region

Quelle: ClinicalTrials.gov

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