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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT06375798
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • radiotherapy — PROCEDURE
    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. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Study Details

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.

Key Dates

First listed
Apr 19, 2024
Start date
Nov 19, 2020
Status verified
Sep 2025
Primary completion
Nov 19, 2026
Completion
Nov 19, 2026

Study Design

Enrollment
620 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

LRFS [ Time Frame: At least 5 years ]

Central Contacts

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