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Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 190 to 506 · Primary completion date: Dec 31, 2025 to Mar 27, 2029 · Start date changed from estimate of Aug 10, 2025 to Mar 27, 2026 · 3 morev2 Show 6 more changesShow less
    • Enrollment target: 190 to 506
    • Primary completion date: Dec 31, 2025 to Mar 27, 2029
    • Start date changed from estimate of Aug 10, 2025 to Mar 27, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (10)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction. Intervention: HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
Trial Details
NCT Number NCT07084519
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Breast Cancer, Breast Reconstruction, Radiation Oncology
Enrollment 506 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov