Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

A Single-center, open, prospective study,for 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 55
Healthy Volunteers: t
View:

• Age ≥55 years old;

• Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0;

• Patients who are willing to preserve milk and intend to undergo breast-conserving surgery;

• If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm;

• ER≥ 30% and PR≥ 1%, HER2 negative;

• Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.

Locations
Other Locations
China
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
cuizhi GENG, archiater
gengcuizhi@hotmail.com
135 0321 6325
Backup
meiqi WANG, attending
maggie92320@hotmail.com
186 3305 1639
Time Frame
Start Date: 2020-11-19
Estimated Completion Date: 2026-11-19
Participants
Target number of participants: 620
Treatments
IORT group
The IORT group received intraoperative radiotherapy with a regimen of 50-KV-X 20Gy/1f.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.
WBI group
WBI group received whole milk external irradiation with a regimen of 50Gy/25f.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.
Related Therapeutic Areas
Sponsors
Leads: Hebei Medical University Fourth Hospital

This content was sourced from clinicaltrials.gov