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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
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
Reconstruction Failure Rate
implant removal, capsular contracture ≥ Baker grade III
Time frame: 2 year
Other Implant-Related Adverse Events
infection, skin necrosis, implant exposure
Time frame: 2 year
Radiation-Related Toxicities
grade ≥3 dermatitis, pneumonitis, lymphedema
Time frame: 2 year
DFS
Disease-Free Survival
Time frame: 5 year
OS
Overall Survival
Time frame: 5 year
LRR
Locoregional Recurrence Rate
Time frame: 5 year
DM
Distant Metastasis Rate
Time frame: 5 year
Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)
Physicians will assess cosmetic outcome using the Harvard Breast Cosmesis Scale. Unit of Measure: Score on Harvard Breast Cosmesis Scale Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse cosmetic outcomes.
Time frame: 1 year
Patient-Reported Cosmetic Outcome
Description: Patients will self-assess cosmetic outcome using a 4-point Likert scale. Unit of Measure: Score on 4-point Likert scale. Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse perceived outcome.
Time frame: 1 year
Quality of Life Assessed by EORTC QLQ-C30 Global Health Status Score
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) will be used to evaluate patients' global health status and overall quality of life. Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100; higher scores indicate better global health status.
Time frame: Baseline, 6 months, and 12 months after treatment
Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module
The EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23) will be used to assess breast cancer-specific quality of life. Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100. For functional scales, higher scores indicate better function; for symptom scales, higher scores indicate worse symptoms.
Time frame: Baseline, 6 months, and 12 months after treatment
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