RecruitingNot ApplicableNCT05512286

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

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


Sponsor

Fudan University

Enrollment

80 participants

Start Date

Aug 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to timing radiation therapy for breast cancer patients who need a mastectomy followed by breast reconstruction using their own tissue (called a DIEP flap): radiation before surgery (pre-operative) versus radiation after reconstruction (post-mastectomy). The goal is to find out which timing leads to better outcomes and quality of life. **You may be eligible if...** - You have invasive breast cancer confirmed by biopsy - Your cancer is at a stage that requires chemotherapy before surgery (neoadjuvant chemotherapy) and will also need radiation - You do not have cancer spread to distant organs - You are a suitable candidate for DIEP flap reconstruction at the time of mastectomy **You may NOT be eligible if...** - Your cancer worsened during neoadjuvant chemotherapy - You have a history of diabetes or heavy smoking (both can affect wound healing) - You are pregnant or breastfeeding - You are enrolled in another clinical trial that could affect outcomes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPreoperative radiotherapy

Radiotherapy followed by mastectomy and DIEP flap reconstruction

RADIATIONPostmastectomy 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

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NCT05512286


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