Adaptive Radiotherapy in Head and Neck Tumor Patients

Rekrutierend

NCT-Nummer:
NCT06216171

Studienbeginn:
Januar 2024

Letztes Update:
09.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienlocations
(1 von 1)

Maja Guberina
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maja W Strahlentherapie
Phone: +492017232321
E-Mail: maja.guberina@uk-essen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with

radiochemotherapy with curative intent. If the field-set UP margins are broad, the

consequence may be that quality of life is impaired. The study group of Nutting et al. (2023)

investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can

reduce the radiation dose to structures associated with dysphagia and aspiration and improve

swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney

K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus

standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023

Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group

concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported

swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard

of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further

improve outcomes.

Thus, in this trial we analyze ART in head and neck cancer in a prospective randomized trial.

Ein-/Ausschlusskriterien

Inclusion Criteria:

ECOG 0/1 No prior cancer treatment

Exclusion Criteria:

ECOG 2-4 Prior cancer treatment

Studien-Rationale

Primary outcome:

1. EORTC CTC AE Score (Time Frame - 2 months - 5 years):
quality of life, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017

2. Dysphagia score (Time Frame - 2 months - 5 years):
Dysphagia score

Secondary outcome:

1. Overall Survival (Time Frame - 2-5 years):
Overall Survival

2. Progression Free Survival (Time Frame - 2-5 years):
Progression Free Survival

Studien-Arme

Experimental: Adaptive Radiotherapy
Adaptive Radiotherapy, online onboard adaptation of the dosis to actual anatomy of the day by a specialist of radiation oncology and a medical physicist
Active Comparator: Standard conventional Treatment Arm, IGRT
Standard treatment option, image guided radiotherapy without online adaptation

Geprüfte Regime

Adaptive Radiotherapy:
Adaptive Radiotherapy
image guided radiotherapy without online adaptation:
image guided radiotherapy without online adaptation

Quelle: ClinicalTrials.gov