Clinical Research Directory

Hypofractionated Radiotherapy After Breast Reconstruction for Breast Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

Summary

This study aims to evaluate the efficacy and safety of hyperfractionated radiotherapy (40Gy/15 fractions) compared to conventional fractionated radiotherapy (50Gy/25 fractions) in breast cancer patients undergoing breast reconstruction through a three-phase randomized controlled non-inferiority clinical trial. The primary objective is to verify that hyperfractionated radiotherapy is non-inferior to conventional fractionated radiotherapy in terms of local area control; the secondary objectives are to compare the main complications of wounds, acute and chronic toxic reactions, breast cosmetic effects, and quality of life between the two groups, thereby providing high-level evidence-based medical evidence for optimizing postoperative radiotherapy regimens for breast cancer and promoting individualized treatment. Additionally, the molecular characteristics of blood samples will be studied to identify biomarkers related to the radiotherapy process and treatment response, providing high-level evidence for immediate medium-dose low-fractionation radiotherapy after different reconstructions.

Official title: Comparison of Efficacy and Safety Between Hypofractionated and Conventional Fractionated Radiotherapy After Breast Reconstruction in Breast Cancer Patients: A Phase III Randomized Controlled Clinical Trial

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