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RECRUITING
NCT05512286
NA

Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction

Sponsor: Fudan University

View on ClinicalTrials.gov

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

RADIATION

Preoperative radiotherapy

Radiotherapy followed by mastectomy and DIEP flap reconstruction

RADIATION

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