Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter，Prospective，Open-label，Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Patient satisfaction with breasts questionnaire Patient satisfaction of breast
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histological proven invasive breast cancer;
- •Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;
- •No distant metastasis;
- •Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.
排除标准
- •Patients enrolled in other clinical trial which may as influence the outcome;
- •Patients received neoadjuvant therapy without radiotherapy indications；
- •Disease progression during neoadjuvant chemotherapy；
- •Patients of pregnancy or lactation；
- •Previous history of diabetes；
- •Previous history of heavy smoking.
结局指标
主要结局
Patient satisfaction with breasts questionnaire Patient satisfaction of breast
时间窗: 24 months after surgery
Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.
次要结局
- Complications of radiotherapy(3 months, 12 months, and 24 months after radiotherapy)
- Failure rate of breast reconstruction surgery(8 weeks after surgery)
- Patient satisfaction with outcome questionnaire(3months, 12 months, and 24 months after surgery)
- Aesthetic evaluation(12 months and 24 months after surgery)
- Total pathologic complete response (tpCR)(up to 4 weeks after surgery)
- Complications of surgery(3 months, 12 months, and 24 months)
- 3-year disease free survival (DFS)(3 years after diagnosis)