Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Xiangyun Zong80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Quality of Life

Interventions

intraoperative radiotherapyRADIATION

intraoperative radiotherapy

postoperative radiotherapyRADIATION

postoperative radiotherapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Rate of successful surgical procedure

the rate of successful breast conserving surgery

Time frame: immediately after surgery

satisfaction with conserved breast

the patients' satisfaction to postoperative breast including shape and feeling(Harvard/NSABP/RTOG BREAST COSMETIC SCALE: excellent, good, fair, poor)

Time frame: 1 month after surgery

Secondary Outcomes

Rate of acute and chronic postoperative complications（CTCAE 3.0)

The incidence of adverse reactions at 1 and 6 months after operation

Time frame: 1-month, 6-month after surgery

DFS

long-term postoperative disease-free survival

Time frame: 2-3 years after surgery

long-term postoperative overall survival

Time frame: 2-3 years after surgery

Data from ClinicalTrials.gov

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