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

RecruitingNAAges 18 Years - anyFemaleFudan University
NCT05512286 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Preoperative radiotherapy
  • Postmastectomy radiotherapy
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Where

6 sites
Guangxi Provincial Cancer Hospital
Nanning, China
Henan Provincial Cancer Hospital
Zhengzhou, China
Hunan Provincial Cancer Hospital
Changsha, China
Huashan Hospital of Fudan University
Shanghai, China
Yunnan Provincial Cancer Hospital
Kunming, China
Zhejiang Provincial Cancer Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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