Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Not Applicable

Active, not recruiting

• Conditions: Quality of Life
• Interventions: Radiation: intraoperative radiotherapy; Radiation: postoperative radiotherapy

• Registration Number: NCT04789889
• Lead Sponsor: Xiangyun Zong

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2024-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IORT	intraoperative radiotherapy	intraoperative radiotherapy(IORT) in BCS.
PORT	postoperative radiotherapy	traditional postoperative radiotherapy following BCS.

Primary Outcome Measures

Name	Time	Method
Rate of successful surgical procedure	immediately after surgery	the rate of successful breast conserving surgery
satisfaction with conserved breast	1 month after surgery	the patients' satisfaction to postoperative breast including shape and feeling(Harvard/NSABP/RTOG BREAST COSMETIC SCALE: excellent, good, fair, poor)

Secondary Outcome Measures

Name	Time	Method
Rate of acute and chronic postoperative complications（CTCAE 3.0)	1-month, 6-month after surgery	The incidence of adverse reactions at 1 and 6 months after operation
DFS	2-3 years after surgery	long-term postoperative disease-free survival
OS	2-3 years after surgery	long-term postoperative overall survival

Trial Locations

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China