Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214611
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-12-28
Brief Title:
Prospective Validation of Adaptive Radiotherapy ART in Patients With Head and Neck Tumors
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART in HNT
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00033144 | OTHER | DRKS Deutsches Register Klinischer Studien | None |