Clinical trial NCT04789889: Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery
Official title: Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Keywords: intraoperative radiotherapy
breast-conserving surgery
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 ≤ 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.

Primary outcomes:
measure: Rate of successful surgical procedure
timeFrame: immediately after surgery
measure: satisfaction with conserved breast
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Rate of acute and chronic postoperative complications（CTCAE 3.0)
timeFrame: 1-month, 6-month after surgery
measure: DFS
timeFrame: 2-3 years after surgery
measure: OS
timeFrame: 2-3 years after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University affiliated 6th Hospital
name: ZONG, MD, PhD
role: STUDY_DIRECTOR
References:
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