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Prospective validation of Adaptive Radiotherapy in patients with head and neck tumors

Prospective validation of Adaptive Radiotherapy in patients with head and neck tumors - ART in head and neck region

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033144
Enrollment
30
Registered
2023-12-04
Start date
2023-11-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Head- and Neckregion, C00-C14, C40-44, C73-C97 C00-C14 C40-C41 C43-C44 C73-C75 C76-C80 C81-C96 C97

Interventions

Group 1: Adaptive radiotherapy (combination IGRT/IMRT/VMAT and ART), the sessions of an RT series are evaluated and compared onboard with the standard radiotherapy option (Plan comparison is possible

Sponsors

Klinik für Strahlentherapie, Universitätsklinikum Essen, NCT West
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ECOG performance status 0 or 1

Exclusion criteria

Exclusion criteria: ECOG 2-4, other malignant tumor

Design outcomes

Primary

MeasureTime frame
Dose distribution and effective uniform dose in the CTV over the first 7 fractions =95%, or <95%: (The primary endpoint is the accumulated dose distribution in the CTV with the initial treatment plan approved for the series over fractions 1-7 of each patient up to the time of the 10th fraction for each patient in this study and from this the effective uniform dose in the CTV is calculated)

Secondary

MeasureTime frame
Minimal isotropic PTV margin, progression free survival (PFS), overall survival (OS), dose organs at risk (OAR), side effects (CTC AE, LENT-SOMA); quality of life (EORTC), minimal PTV margin, coverage of the CTV with an equivalent uniform dose (EUD) of =95% of the prescribed dose

Countries

Germany

Contacts

Public ContactMaja Guberina

Klinik für Strahlentherapie, Universiätsklinikum Essen, NCT West

maja.guberina@uk-essen.de020172383121

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026