Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720078
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-01-06
Brief Title:
UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 UNITED-3
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 UNITED-3 Applying a Two Phase Personalized Margin Reduced Clinical Target Volume Approach
Status:
RECRUITING
Status Verified Date:
2024-04
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:
UNITED-3
Brief Summary:
The goal of this study is to test whether an adaptive radiation therapy RT two-phase approach in participants with glioblastoma impacts local control compared to standard non-adaptive RT approach The main questions of the study are to see how this adaptive two-phase RT approach compares to standard RT in terms of
Local control
Overall and progression-free survival
Patterns of failure
Toxicity Neurological Function and Quality of Life
Local control
Overall and progression-free survival
Patterns of failure
Toxicity Neurological Function and Quality of Life
Detailed Description:
Glioblastoma GBM is a high grade glioma brain tumor that is treated with surgery or biopsy followed by radiotherapy RT given daily over 6 weeks with or without an oral chemotherapy Radiation is targeted to the visible residual tumor on magnetic resonance imaging MRI images plus a large margin of 15 to 30 mm to account for possible cancer cells outside the visible tumor and for potential growth or shifts in tumor position throughout the prolonged RT course Standard RT uses MRI to create a reference plan with large margins and treats that same volume every day This exposes a large amount of healthy brain tissue to radiation leading to toxicity and reduced quality of life
A new technology the MR-Linac combines an MRI scanner and a Linac radiation delivery machine into one unit This allows for adaptive RT by obtaining an updated MRI scan each day just prior to treatment adapting the RT plan to take into account any changes in the tumor or the patients anatomy on that given day This allows for a smaller 5 mm margin on the visible tumor as its position can be tracked daily The goal of this study is to use adaptive RT with small margins with a two-phase approach to test the impact on local control of the visible tumor compared to the large volumes used with standard non-adaptive RT as well as impacts on neurocognitive function and quality of life
A new technology the MR-Linac combines an MRI scanner and a Linac radiation delivery machine into one unit This allows for adaptive RT by obtaining an updated MRI scan each day just prior to treatment adapting the RT plan to take into account any changes in the tumor or the patients anatomy on that given day This allows for a smaller 5 mm margin on the visible tumor as its position can be tracked daily The goal of this study is to use adaptive RT with small margins with a two-phase approach to test the impact on local control of the visible tumor compared to the large volumes used with standard non-adaptive RT as well as impacts on neurocognitive function and quality of life
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