Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04789889

Enrollment

Registered

2021-03-10

Start date

2021-03-01

Completion date

2025-02-28

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

intraoperative radiotherapy, breast-conserving surgery

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).

Interventions

RADIATIONintraoperative radiotherapy

intraoperative radiotherapy

RADIATIONpostoperative radiotherapy

postoperative radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026