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

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

Overview

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.

Interventions

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

Primary outcome measures

• Patient satisfaction with breasts questionnaire Patient satisfaction of breast [Time frame: 24 months after surgery]

Secondary outcome measures (7)

• Complications of surgery [Time frame: 3 months, 12 months, and 24 months]
• Complications of radiotherapy [Time frame: 3 months, 12 months, and 24 months after radiotherapy]
• Failure rate of breast reconstruction surgery [Time frame: 8 weeks after surgery]
• Patient satisfaction with outcome questionnaire [Time frame: 3months, 12 months, and 24 months after surgery]
• Aesthetic evaluation [Time frame: 12 months and 24 months after surgery]
• Total pathologic complete response (tpCR) [Time frame: up to 4 weeks after surgery]
• 3-year disease free survival (DFS) [Time frame: 3 years after diagnosis]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• Guangxi Provincial Cancer Hospital — Nanning
• Henan Provincial Cancer Hospital — Zhengzhou
• Hunan Provincial Cancer Hospital — Changsha
• Huashan Hospital of Fudan University — Shanghai
• Yunnan Provincial Cancer Hospital — Kunming
• Zhejiang Provincial Cancer Hospital — Hangzhou

Publications

• 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 O PMID 39832996

Identifiers

NCT: NCT05512286 · CBCSG041

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗