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Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
Sponsor: Fudan University
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-08-25
Completion Date
2027-10-01
Last Updated
2024-11-25
Healthy Volunteers
No
Conditions
Interventions
Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction
Locations (6)
Guangxi Provincial Cancer Hospital
Nanning, Guangxi, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Hunan Provincial Cancer Hospital
Changsha, Hunan, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China