Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

Study Overview
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Brief Summary
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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).

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

Conditions
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Quality of Life

Intervention / Treatment
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* Radiation: intraoperative radiotherapy
* Radiation: postoperative radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IORT<br>intraoperative radiotherapy(IORT) in BCS. | Radiation: intraoperative radiotherapy<br>* intraoperative radiotherapy<br>|
| Active Comparator: PORT<br>traditional postoperative radiotherapy following BCS. | Radiation: postoperative radiotherapy<br>* postoperative radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful surgical procedure | the rate of successful breast conserving surgery | 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) | 1 month after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative radiotherapy, breast-conserving surgery