Breast Cancer
Conditions
Interventions
IORT group: The IORT group will receive Intrabeam targeted IORT with a single dose of 20 Gy, followed by postoperative WBI with external beam irradiation of 50 Gy in 25 fractions.
PORT group:The PORT group will receive conventional external-beam WBI (50 Gy in 25 fractions) followed by a tumor bed boost of 10-16 Gy in 5-8 fractions.
Sponsors
China-Japan Union Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.18 years old <= age <= 70 years old 2.the maximum diameter of the primary lesion was <= 5cm 3. tumor stage T1-2/N0-1/M0 4. the volume ratio of tumor to breast is appropriate 5. confirmed as monocentric lesions suitable for local resection 6. the cosmetic shape of the breast can be preserved after OPS (volume displacement) All patients are required to complete breast ultrasound, mammography, breast MRI, and related preoperative routine examinations before the operation. All patients are required to receive needle biopsy and pathological diagnosis of primary breast cancer before the operation.
Exclusion criteria
Exclusion criteria: 1. patients who refuse BCS and radiotherapy; 2. patients with preoperative neoadjuvant therapy; 3. multicentric lesions; 4. patients with difficult to achieve negative surgical margin; 5. patients with inflammatory breast cancer; 6. patients with a history of thoracic radiotherapy; 7. patients in pregnancy; 8. patients with active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| cosmetic outcomes;Ipsilateral breast tumor recurrence, IBTR;Local regional recurrence, LRR;Disease-free survival, DFS;Breast cancer specific survival, BCSS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWan Wang
Department of Breast Surgery, China-Japan Union Hospital of Jilin University
Outcome results
None listed