NCT06214611

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
20mo left

Started Nov 2023

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Nov 2023Dec 2027

Study Start

First participant enrolled

November 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Expected
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

December 28, 2023

Last Update Submit

September 25, 2024

Conditions

Head and Neck CancerAdaptive RadiotherapyRadiationOptimized TreatmentProtection of Organs at RiskDysphagia Reduction

Keywords

Head and Neck CancerAdaptive RadiotherapyProtection of organs at riskOptimized treatmentDysphagia reduction

Outcome Measures

Primary Outcomes (1)

  • Accumulated dose distribution in CTV

    accumulated dose distribution in the clinical target volume, EUD \[Gy\]

    2 weeks

Secondary Outcomes (8)

  • dysphagia assessment scores

    2 weeks to 5 years

  • Minimally isotropic PTV margin

    2 months

  • Progression free survival (PFS)

    2 months to 5 years

  • overall survival (OS)

    2 months to 5 years

  • dose organs at risk (OAR)

    2 weeks

  • +3 more secondary outcomes

Study Arms (2)

Adaptive Radiotherapy

OTHER

Adaptive Radiation Therapy

Radiation: Adaptive Radiotherapy

Standard Treatment Arm, IGRT

ACTIVE COMPARATOR

Standard Treatment Arm, IGRT

Radiation: Adaptive Radiotherapy

Interventions

Adaptive RadiotherapyRADIATION

Adaptive Radiotherapy in the head and neck region

Also known as: Dysphagia optimized Adaptive Radiotherapy (ART)
Adaptive RadiotherapyStandard Treatment Arm, IGRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG 0-1
  • Histopathology confirmation
  • Compliance
  • Tumor in the head and neck region
  • Indication for radiotherapy

You may not qualify if:

  • \. Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Essen, Germany / NRW, 45147, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26460989BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist

CONTACT

+492017232321maja.guberina@uk-essen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. (MD) Maja Guberina, specialist in radiation oncology, senior consultant

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 19, 2024

Study Start

November 15, 2023

Primary Completion

December 15, 2024

Study Completion (Estimated)

December 15, 2027

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)