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NOT YET RECRUITING
NCT07084519
PHASE3

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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

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

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