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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Hunan Cancer Hospital | OTHER |
| Cancer Hospital of Guangxi Medical University | OTHER |
| Yunnan Cancer Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative radiotherapy | Experimental | Radiotherapy followed by mastectomy and DIEP flap reconstruction |
|
| Postmastectomy radiotherapy | Active Comparator | Radiotherapy after mastectomy and DIEP flap reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative radiotherapy | Radiation | Radiotherapy followed by mastectomy and DIEP flap reconstruction |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of surgery | Complications of surgery | 3 months, 12 months, and 24 months |
| Complications of radiotherapy | Complications of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong Wu | Contact | 862164175590 | wujiong1122@vip.sina.com | |
| Shuang Hao | Contact | 862164175590 | hzz50@hotmail.co, |
| Name | Affiliation | Role |
|---|---|---|
| Jiong Wu | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Provincial Cancer Hospital | Recruiting | Nanning | Guangxi | 530021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39832996 | Derived | Hao S, Hou J, Zhang L, Zhou C, Hou Y, Yu K, Hu Z, Liu G, Di G, Shao ZM, Yu X, Wu J. Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China. BMJ Open. 2025 Jan 20;15(1):e086980. doi: 10.1136/bmjopen-2024-086980. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
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| Postmastectomy radiotherapy | Radiation | Radiotherapy after mastectomy and DIEP flap reconstruction |
|
| 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 |
| Henan Provincial Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Hunan Provincial Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
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| Huashan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Yunnan Provincial Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Zhejiang Provincial Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |