Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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)
Eligibility criteria
Qualifiers
Female, aged 18-75 years
Karnofsky Performance Status ≥60
Histopathologically confirmed invasive breast adenocarcinoma
Total mastectomy [with or without nipple-areolar complex preservation] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
Disqualifiers
Prior radiotherapy to chest wall or nodal regions
Pregnancy or lactation
T4 stage disease
Autologous breast reconstruction of the irradiated breast
Trial design
Treatments tested in this trial
- hypofractionated radiotherapy
- conventional fractionated radiotherapy
Treatment groups
506 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov