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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age55+
SponsorHebei Medical University Fourth Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Simultaneous diagnosis of bilateral or multifocal breast cancer;

Previous ipsilateral breast cancer and/or prior chest wall radiation therapy;

There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest;

The investigators did not consider the patient suitable for participation in any other conditions of the study.

Trial population

The clinical stage of Tis-1N0M0 in patients undergoing breast conserving surgery for early breast cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • radiotherapy

    Procedure/Surgery

    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.

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: IORT group1 intervention
Group B: WBI group1 intervention

Trial outcomes

Primary outcomes

1

LRFS

There was no local recurrence survival

Time frame
At least 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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