Comparing preoperative and postoperative radiotherapy in breast cancer patients undergoing 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

This study is testing whether giving radiation therapy before or after surgery helps women with advanced breast cancer who are getting DIEP flap reconstruction feel better and have fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Nanning, Guangxi and 5 other locations)
• Trial ID: NCT05512286 on ClinicalTrials.gov

What this trial studies

This study evaluates the patient-reported outcomes and safety of preoperative versus postoperative radiotherapy in patients with locally advanced breast cancer undergoing DIEP flap reconstruction. It is a prospective randomized study that aims to determine if administering radiotherapy before mastectomy can reduce adverse effects on healthy tissues and prevent delays in subsequent treatments. The study will include patients who require neoadjuvant chemotherapy and are suitable for DIEP flap reconstruction. By comparing these two approaches, the study seeks to identify the most effective timing for radiotherapy in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically proven invasive breast cancer who require neoadjuvant chemotherapy and are suitable for DIEP flap reconstruction.

Not a fit: Patients with distant metastasis, those who have received neoadjuvant therapy without radiotherapy indications, or those with a history of diabetes or heavy smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and quality of life for breast cancer patients undergoing reconstruction.

How similar studies have performed: Other studies have explored similar approaches, but this specific comparison of preoperative and postoperative radiotherapy in the context of DIEP flap reconstruction is novel.

Eligibility criteria

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.

Where this trial is running

Nanning, Guangxi and 5 other locations

• Guangxi Provincial Cancer Hospital — Nanning, Guangxi, China (Recruiting)
• Henan Provincial Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Hunan Provincial Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Huashan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Yunnan Provincial Cancer Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Provincial Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jiong Wu — Fudan University
• Study coordinator: Jiong Wu

Conditions Breast Cancer; DIEP flap; radiotherapy; breast cancer