Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Reconstruction Failure Rate
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •pT3 or N2-3 disease; or pT1-2N1
- •No distant metastasis
- •Completed standard neoadjuvant/adjuvant chemotherapy cycles
- •≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy
- •Signed informed consent
排除标准
- •Prior radiotherapy to chest wall or nodal regions
- •Pregnancy or lactation
- •T4 stage disease
- •Autologous breast reconstruction of the irradiated breast
- •Pre-radiotherapy local/regional/distant metastasis
- •Grade ≥3 implant-related adverse events irreversible before radiotherapy
- •Bilateral breast cancer requiring bilateral radiotherapy
- •Concurrent/secondary malignancy with disease-free interval <5 years [except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ]
- •Active collagen vascular disease, e.g., SLE, scleroderma
- •Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders
研究组 & 干预措施
CFRT group
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
干预措施: conventional fractionated radiotherapy (Radiation)
HFRT group
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
干预措施: hypofractionated radiotherapy (Radiation)
结局指标
主要结局
Reconstruction Failure Rate
时间窗: 2 year
implant removal, capsular contracture ≥ Baker grade III
次要结局
- Quality of Life Assessed by BREAST-Q (Breast Reconstruction Module), Version 2.0(Baseline, 6 months, and 12 months after treatment)
- DFS(5 year)
- Other Implant-Related Adverse Events(2 year)
- Radiation-Related Toxicities(2 year)
- OS(5 year)
- LRR(5 year)
- DM(5 year)
- Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)(1 year)
- Patient-Reported Cosmetic Outcome(1 year)
- Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module(Baseline, 6 months, and 12 months after treatment)
研究者
Shulian Wang,MD
Professor of radiation oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences