NCT07835139招募中不适用
Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- The rate of unplanned reoperation
研究概览
简要总结
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18 years.
- •Pathologically confirmed unilateral primary invasive breast cancer.
- •Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection).
- •Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement.
- •Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols.
- •Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0).
- •Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy.
- •ECOG performance status 0-
- •Prior non-breast malignancy permitted if disease-free for > 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval.
- •Estimated life expectancy ≥ 10 years.
- •Written informed consent provided.
排除标准
- •Pregnant or lactating patients.
- •Prior history of breast cancer.
- •Bilateral breast cancer.
- •Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.
- •T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy).
- •Non-breast malignancy within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma).
- •Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.
研究组 & 干预措施
Conventionally fractionated radiotherapy
Active Comparator
干预措施: ConvRT (Radiation)
Hypofractionated radiotherapy
Experimental
干预措施: HypoRT (Radiation)
结局指标
主要结局
The rate of unplanned reoperation
时间窗: 3 years
Surgery performed to treat complications related to breast reconstruction.
次要结局
- Overall survival(5 years)
- Implant-Based Breast Reconstruction Complications(3 years)
- Locoregional recurrence(5 years)
- Distant metastasis(5 years)
研究者
研究点 (1)
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