Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185062
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-12-14
Brief Title:
Pelvic Cancer Registry for Online Adapted Radiotherapy
Sponsor:
University Medical Center Goettingen
Organization:
University Medical Center Goettingen
Study Overview
Official Title:
Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy A Prospective Registry-based Phase-II Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
PRoART
Brief Summary:
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT For the primary endpoint and the secondary clinical endpoints the trial will compare oART versus IGRT for technical endpoints the trial will compare the real oART scenario with two virtual hypothetical control scenarios
Primary endpoint
10 reduction in the rate of acute radiotherapy related toxicity CTCAE II v50 using oART
Secondary endpoints
Clinical endpoints Tumor control late toxicities compared to conventional irradiated patients quality of life and patient-reported outcomes
Technical endpoints Target volume target coverage dose to organs at risk anatomical variability score
Primary endpoint
10 reduction in the rate of acute radiotherapy related toxicity CTCAE II v50 using oART
Secondary endpoints
Clinical endpoints Tumor control late toxicities compared to conventional irradiated patients quality of life and patient-reported outcomes
Technical endpoints Target volume target coverage dose to organs at risk anatomical variability score
Detailed Description:
Background Conventional Radiotherapy Image Guided Radiotherapy IGRT requires a CT-based treatment planning process a priori During this process a treatment plan is calculated which then is applied to the patient with a linear accelerator on a daily basis possibly using image guidance to account for variability in patient position However daily changes of the anatomy of targets and organs at risk OARs can only be addressed by applying additional safety margins resulting in larger irradiated volumes and possibly higher toxicity
A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy oART using daily imaging to create a plan of the day aligned to the actual anatomy by means of artificial intelligence AI and with the patient on the treatment couch This approach is especially promising in the pelvic region due to the high anatomic variability eg caused by peristalsis or volume changes of bladder and rectum Furthermore the application of oART in the field of thoracic tumors is being evaluated oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention A direct comparison of both techniques IGRT vs oART is missing
Methods This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT For the primary endpoint and the secondary clinical endpoints the trial will compare oART versus IGRT for technical endpoints the trial will compare the real oART scenario with two virtual hypothetical control scenarios as follows
oART - Applied treatment AI-based daily treatment plan creation adapted to daily anatomy
Virt 1 - Hypothetical dose distribution of initial treatment plan based on the initial planning CT
Virt 2 - Hypothetical dose distribution of initial treatment plan applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine
A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy oART using daily imaging to create a plan of the day aligned to the actual anatomy by means of artificial intelligence AI and with the patient on the treatment couch This approach is especially promising in the pelvic region due to the high anatomic variability eg caused by peristalsis or volume changes of bladder and rectum Furthermore the application of oART in the field of thoracic tumors is being evaluated oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention A direct comparison of both techniques IGRT vs oART is missing
Methods This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT For the primary endpoint and the secondary clinical endpoints the trial will compare oART versus IGRT for technical endpoints the trial will compare the real oART scenario with two virtual hypothetical control scenarios as follows
oART - Applied treatment AI-based daily treatment plan creation adapted to daily anatomy
Virt 1 - Hypothetical dose distribution of initial treatment plan based on the initial planning CT
Virt 2 - Hypothetical dose distribution of initial treatment plan applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None