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

Breast Cancer Clinical Trial

— CAPPELLA  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512286
• Other study ID #: CBCSG041
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 1, 2027

Study information

• Verified date: August 2022
• Source: Fudan University
• Contact: Jiong Wu
• Phone: 862164175590
• Email: wujiong1122[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
• Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

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