Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Xiangyun Zong

Status: Terminated

Conditions: Quality of Life

Treatments: Radiation: intraoperative radiotherapy; Radiation: postoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04789889

JTU-6H-20210227001

Details and patient eligibility

About

To compare the satisfaction with conserved breast, acute and chronic postoperative complications and tumor control between intraoperative radiotherapy(IORT) and traditional postoperative radiotherapy following breast-conserving surgery (BCS).

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary invasive breast cancer confirmed by pathology.
• Maximum tumor diameter ≤3.5cm.
• Clinical lymph nodes are negative.
• Single or multiple tumors are located on the same side of the nipple and in the same quadrant.
• ECOG status score ≤ 2.
• With informed Consents.

Exclusion criteria

• Previous history of breast cancer or other malignant tumors.
• Inflammatory breast cancer; 3. Previous radiotherapy history.
• Other diseases affecting radiotherapy, such as connective tissue disease, heart disease, lung disease and so on.
• Patients who are not going to have the axillary lymph node surgery (including SLN and ALND) were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

IORT

Experimental group

Description:

intraoperative radiotherapy(IORT) in BCS.

Treatment:

Radiation: intraoperative radiotherapy

PORT

Active Comparator group

Description:

traditional postoperative radiotherapy following BCS.

Treatment:

Radiation: postoperative radiotherapy