Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615466
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-18
Brief Title:
Super-Hypofractionated Partial Breast Irradiation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer a Prospective Single-arm Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Partial breast irradiation is currently a hot topic in clinical research but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive Foreign studies have mostly selected patients with low risk of recurrence Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation 40Gy10f and a 3-week schedule of whole-breast radiotherapy 435Gy15f in patients with early-stage low-risk breast cancer after breast-conserving surgery preliminary results show that the 2-week partial breast irradiation regimen is safe and effective This study plans to continue to select low-risk breast-conserving patients use extracorporeal intensity-modulated radiotherapy technology refer to the radiotherapy dose fractionation model of the FAST-Forward study and give partial breast irradiation 52 Gyfd a total of 5 times with a total dose of 26Gy to further shorten the time The radiotherapy time is 1 week and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed Provide evidence for conducting a national multi-center phase III clinical randomized study
Detailed Description:
None
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