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

RECRUITINGN/ASponsored by Fudan University
Actively Recruiting
PhaseN/A
SponsorFudan University
Started2022-08-25
Est. completion2026-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

Breast CancerCancer

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