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Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
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)
Official title: Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2025-08-10
Completion Date
2030-12-31
Last Updated
2025-07-24
Healthy Volunteers
No
Interventions
hypofractionated radiotherapy
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
conventional fractionated radiotherapy
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
Locations (1)
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, China