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Hypofractionated Radiotherapy After Breast Reconstruction for Breast Cancer

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07831889
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov