This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Radiotherapy after mastectomy and DIEP flap reconstruction
Guangxi Provincial Cancer Hospital
Nanning, Guangxi, China
RECRUITINGHenan Provincial Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHunan Provincial Cancer Hospital
Changsha, Hunan, China
RECRUITINGHuashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGYunnan Provincial Cancer Hospital
Kunming, Yunnan, China
RECRUITINGZhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPatient satisfaction with breasts questionnaire Patient satisfaction of breast
Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.
Time frame: 24 months after surgery
Complications of surgery
Complications of surgery
Time frame: 3 months, 12 months, and 24 months
Complications of radiotherapy
Complications of radiotherapy
Time frame: 3 months, 12 months, and 24 months after radiotherapy
Failure rate of breast reconstruction surgery
Failure rate of breast reconstruction surgery
Time frame: 8 weeks after surgery
Patient satisfaction with outcome questionnaire
Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery
Time frame: 3months, 12 months, and 24 months after surgery
Aesthetic evaluation
Aesthetic evaluation (as measured using the Harris Score) 12 months and 24months after surgery. Breast aesthetic evaluation will subjectively be evaluated by two experts who applied the Harris score giving a mark of 1-4 for a poor to excellent result.
Time frame: 12 months and 24 months after surgery
Total pathologic complete response (tpCR)
pathologic complete response of breast and lymph nodes
Time frame: up to 4 weeks after surgery
3-year disease free survival (DFS)
Oncological safety
Time frame: 3 years after diagnosis
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