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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Preoperative radiotherapy; Radiation: Postmastectomy radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiong Wu; Phone Number: 862164175590; Email: wujiong1122@vip.sina.com
• Study Contact Backup: Name: Shuang Hao; Phone Number: 862164175590; Email: hzz50@hotmail.co,

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Provincial Cancer Hospital
      • Contact: Huawei Yang
      • Contact: Xiaoming Liao
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Provincial Cancer Hospital
      • Contact: Zhenzhen Liu
      • Contact: Xuhui Guo
  • Hunan
    • Changsha, Hunan, China, 410031
      • Recruiting
      • Hunan Provincial Cancer Hospital
      • Contact: Zan Li
      • Contact: Dajiang Song
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital of Fudan University
      • Contact: Qiang Zou
      • Contact: Yiting Jin
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Recruiting
      • Yunnan Provincial Cancer Hospital
      • Contact: Dedian Chen
      • Contact: Sheng Huang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Recruiting
      • Zhejiang Provincial Cancer Hospital
      • Contact: Yang Yu
      • Contact: Jiejie Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative radiotherapy; Radiotherapy followed by mastectomy and DIEP flap reconstruction	Radiation: Preoperative radiotherapy; Radiotherapy followed by mastectomy and DIEP flap reconstruction
Active Comparator: Postmastectomy radiotherapy; Radiotherapy after mastectomy and DIEP flap reconstruction	Radiation: Postmastectomy radiotherapy; Radiotherapy after mastectomy and DIEP flap reconstruction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Zhejiang Cancer Hospital; Huashan Hospital; Henan Cancer Hospital; Hunan Cancer Hospital; Yunnan Cancer Hospital; Cancer Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Jiong Wu, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; radiotherapy; DIEP flap
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CBCSG041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No