Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568705
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery The main questions it aims to answer are
Can online adaptive radiotherapy improve the accuracy of dose delivery
In patients undergoing online adaptive radiotherapy how are the treatment-related toxicities and tumor control outcomes
Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy a dose of 435Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy a dose of 26Gy in 5 fractions
Can online adaptive radiotherapy improve the accuracy of dose delivery
In patients undergoing online adaptive radiotherapy how are the treatment-related toxicities and tumor control outcomes
Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy a dose of 435Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy a dose of 26Gy in 5 fractions
Detailed Description:
Online Adaptive Radiotherapy ART is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition plan design verification and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed Online ART features rapid image acquisition automatic contouring and plan optimization supported by artificial intelligence Body position deviation breast soft tissue deformation and organ movement in different treatment fractions can affect the accuracy of radiotherapy for breast cancer patients Online adaptive radiotherapy is expected to have dosimetric advantages in terms of target coverage and organ-at-risk OAR dose reduction thereby reducing treatment-related side effects while ensuring local tumor control
Moderate hypofractionation 40-435Gy15-16f3w has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens 50Gy25f5w and may even reduce acute and late toxicities Currently moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery In addition the FAST-Forward trial evaluated a shorter regimen the ultrafractionated whole breast radiotherapy 26Gy5f1w and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen The Royal College of Radiologists RCR has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020
Moderate hypofractionation 40-435Gy15-16f3w has been shown to achieve equivalent local tumor control and patient survival compared to traditional fractionationated regimens 50Gy25f5w and may even reduce acute and late toxicities Currently moderate hypofractionationated radiotherapy has been a first-line recommendation for whole breast irradiation following breast cancer surgery In addition the FAST-Forward trial evaluated a shorter regimen the ultrafractionated whole breast radiotherapy 26Gy5f1w and found that local tumor control and normal tissue toxicity were comparable to the moderate hypofractionationated regimen The Royal College of Radiologists RCR has endorsed 5-fraction ultrafractionationated radiotherapy as a standard option for postoperative breast cancer radiation treatment in 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None