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

Study Overview
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Brief Summary
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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
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Preoperative radiotherapy
* Radiation: Postmastectomy radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative radiotherapy<br>Radiotherapy followed by mastectomy and DIEP flap reconstruction | Radiation: Preoperative radiotherapy<br>* Radiotherapy followed by mastectomy and DIEP flap reconstruction<br>|
| Active Comparator: Postmastectomy radiotherapy<br>Radiotherapy after mastectomy and DIEP flap reconstruction | Radiation: Postmastectomy radiotherapy<br>* Radiotherapy after mastectomy and DIEP flap reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with breasts questionnaire Patient satisfaction of breast | Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery. | 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of surgery | Complications of surgery | 3 months, 12 months, and 24 months | 
| Complications of radiotherapy | Complications of radiotherapy | 3 months, 12 months, and 24 months after radiotherapy | 
| Failure rate of breast reconstruction surgery | Failure rate of breast reconstruction surgery | 8 weeks after surgery | 
| Patient satisfaction with outcome questionnaire | Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery | 3months, 12 months, and 24 months after surgery | 
| Aesthetic evaluation | Aesthetic evaluation (as measured using the Harris Score) 12 months and 24months after surgery. Breast aesthetic evaluation will subjectively be evaluated by two experts who applied the Harris score giving a mark of 1-4 for a poor to excellent result. | 12 months and 24 months after surgery | 
| Total pathologic complete response (tpCR) | pathologic complete response of breast and lymph nodes | up to 4 weeks after surgery | 
| 3-year disease free survival (DFS) | Oncological safety | 3 years after diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIEP flap, radiotherapy, breast cancer