CAPPELLA Trial Overview
Study Purpose
The CAPPELLA trial aims to compare patient-reported outcomes (PROs) and safety between preoperative and postoperative radiotherapy for women with locally advanced breast cancer undergoing immediate reconstruction.
Importance of the Study
Postmastectomy radiotherapy (PMRT) can lead to complications and decreased aesthetics in breast reconstruction. This trial evaluates whether preoperative radiotherapy could provide better outcomes.
Trial Design
This is a multicentre, open-label, randomised controlled trial involving nine centers. We will include female patients over 18 years old who are suitable for DIEP flap reconstruction and have received neoadjuvant treatment.
Randomization and Treatment
Patients will be randomly assigned to one of two groups:
- Preoperative Radiotherapy
- Postoperative Radiotherapy
We will treat areas including the breast/chest wall and lymph nodes with a specific radiation dose (42.56 Gy in 16 fractions).
Expected Outcomes
Our primary focus is on patient satisfaction with their breast reconstruction after 2 years, assessed using the BREAST-Q tool. We will also look at PROs at various time points and measure complication rates and tumor responses.
Ethics and Approval
The study follows ethical guidelines and has received approval from the Fudan University Shanghai Cancer Centre ethics committee. Informed consent will be obtained from all participants.
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