Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
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…
Conditions studied
Breast Cancer, Breast Reconstruction, Radiation Oncology
About this study
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)
Interventions
- Radiation: hypofractionated radiotherapy — 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
- Radiation: conventional fractionated radiotherapy — 50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
Primary outcomes
- Reconstruction Failure Rate (2 year)
Eligibility information
Study locations
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Province 10000 China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.