Breast Cancer Clinical Trial
— CAPPELLAOfficial title:
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
Verified date | August 2022 |
Source | Fudan University |
Contact | Jiong Wu |
Phone | 862164175590 |
wujiong1122[@]vip.sina.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | October 1, 2027 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Hunan Provincial Cancer Hospital | Changsha | Hunan |
China | Zhejiang Provincial Cancer Hospital | Hangzhou | Zhejiang |
China | Yunnan Provincial Cancer Hospital | Kunming | Yunnan |
China | Guangxi Provincial Cancer Hospital | Nanning | Guangxi |
China | Huashan Hospital of Fudan University | Shanghai | Shanghai |
China | Henan Provincial Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Cancer Hospital of Guangxi Medical University, Henan Cancer Hospital, Huashan Hospital, Hunan Cancer Hospital, Yunnan Cancer Hospital, Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complications of surgery | Complications of surgery | 3 months, 12 months, and 24 months | |
Secondary | Complications of radiotherapy | Complications of radiotherapy | 3 months, 12 months, and 24 months after radiotherapy | |
Secondary | Failure rate of breast reconstruction surgery | Failure rate of breast reconstruction surgery | 8 weeks after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Total pathologic complete response (tpCR) | pathologic complete response of breast and lymph nodes | up to 4 weeks after surgery | |
Secondary | 3-year disease free survival (DFS) | Oncological safety | 3 years after diagnosis |
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