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

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 design

Treatments tested in this trial

  • radiotherapy

Treatment groups

620 Participants
are divided into 2 treatment groups