Prospective Validation of Adaptive Radiotherapy (ART) in... | NCT06214611

ID	Type	Description	Link
DRKS00033144	Other Identifier	DRKS, Deutsches Register Klinischer Studien

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,)

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Dec 15, 2024Estimated

Completion Date

Dec 15, 2027Estimated

First Submitted Date

Dec 28, 2023

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2024

Last Update Posted Date

Sep 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maja Guberina, PD Dr. med. (MD) Maja Guberina, specialist in radiation oncology, senior consultant, University Hospital, EssenPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adaptive Radiotherapy	Other	Adaptive Radiation Therapy	Radiation: Adaptive Radiotherapy
Standard Treatment Arm, IGRT	Active Comparator	Standard Treatment Arm, IGRT	Radiation: Adaptive Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adaptive Radiotherapy	Radiation	Adaptive Radiotherapy in the head and neck region	Adaptive Radiotherapy Standard Treatment Arm, IGRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accumulated dose distribution in CTV	accumulated dose distribution in the clinical target volume, EUD [Gy]	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
dysphagia assessment scores	dysphagia assessment scores	2 weeks to 5 years
Minimally isotropic PTV margin	Minimally isotropic PTV margin [mm]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist	Contact	+492017232321		maja.guberina@uk-essen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West	Recruiting	Essen	Germany / NRW	45147	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26460989	Background	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms