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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Preoperative radiotherapy; Radiation: Postmastectomy radiotherapy

• Registration Number: NCT05512286
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2022-08-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-07-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative radiotherapy	Preoperative radiotherapy	Radiotherapy followed by mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapy	Postmastectomy radiotherapy	Radiotherapy after mastectomy and DIEP flap reconstruction

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with breasts questionnaire Patient satisfaction of breast	24 months after surgery	Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Complications of radiotherapy	3 months, 12 months, and 24 months after radiotherapy	Complications of radiotherapy
Failure rate of breast reconstruction surgery	8 weeks after surgery	Failure rate of breast reconstruction surgery
Patient satisfaction with outcome questionnaire	3months, 12 months, and 24 months after surgery	Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery
Aesthetic evaluation	12 months and 24 months after surgery	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.
Total pathologic complete response (tpCR)	up to 4 weeks after surgery	pathologic complete response of breast and lymph nodes
Complications of surgery	3 months, 12 months, and 24 months	Complications of surgery
3-year disease free survival (DFS)	3 years after diagnosis	Oncological safety

Trial Locations

Locations (6)

Guangxi Provincial Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

Henan Provincial Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hunan Provincial Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Yunnan Provincial Cancer Hospital; 🇨🇳 Kunming, Yunnan, China

Zhejiang Provincial Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China