Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375798
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
Sponsor:
Hebei Medical University Fourth Hospital
Organization:
Hebei Medical University Fourth Hospital
Study Overview
Official Title:
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
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:
None
Brief Summary:
A Single-center open prospective studyfor analyzing the local recurrence rate the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery
Detailed Description:
This is a single-center open prospective study A total of 620 breast cancer patients meeting the exclusion criteria were included and assigned to the IORT group and the WBI group according to the patients wishes The IORT group received intraoperative radiotherapy with a regimen of 50-KF-x 20Gy1f and the WBI group received whole milk external irradiation with a regimen of 50Gy25f If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy radiotherapy was initiated within 6 weeks after the end of chemotherapy allowing both endocrine therapy and radiotherapy to be performed simultaneously The clinical standard treatment regimen chemotherapy endocrine therapy etc was developed based on postoperative pathological and immunohistochemical reports
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