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Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

StatusRecruiting
PhaseNot applicable
Started2026-10
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This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.
Trial Details
NCT Number NCT07835139
Lead Sponsor Fudan University
Conditions Breast Cancer, Implant Breast Reconstruction
Enrollment 534 participants
Start Date 2026-10
Primary Completion 2033-10 (estimated)
Study Completion 2035-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-22