Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Xiangyun Zong1 site in 1 country80 target enrollmentMarch 1, 2021

ConditionsQuality of Life

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Quality of Life
Sponsor: Xiangyun Zong
Enrollment: 80
Locations: 1
Primary Endpoint: Rate of successful surgical procedure
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 1, 2021

End Date

February 28, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Xiangyun Zong

Responsible Party

Sponsor Investigator

Principal Investigator

Xiangyun Zong

Director of Breast Cancer

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Eligibility Criteria

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 ≤
•With informed Consents.

Exclusion Criteria

•Previous history of breast cancer or other malignant tumors.
•Inflammatory breast cancer;
•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.

Outcomes

Primary Outcomes

Rate of successful surgical procedure

Time Frame: immediately after surgery

the rate of successful breast conserving surgery

satisfaction with conserved breast

Time Frame: 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 Outcomes

DFS(2-3 years after surgery)
OS(2-3 years after surgery)
Rate of acute and chronic postoperative complications（CTCAE 3.0)(1-month, 6-month after surgery)