NCT03536897招募中不适用
Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- In-Breast Tumor Recurrence (IBTR)
研究概览
简要总结
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0-1
- •Age 65 years or older
- •cT1 or cT2 (≤3.0 cm)
- •Invasive ductal carcinoma histology
- •Estrogen receptor positive (ER+)
- •Grade 1 or Grade 2
- •Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
- •Suitable for breast conserving surgery and radiation therapy
- •Patient must be able to provide study-specific informed consent
排除标准
- •Multi-centric cancer not amenable to single lumpectomy
- •Prior ipsilateral whole breast radiation
- •Known BRCA 1 or BRCA 2 mutation
- •Status post neoadjuvant hormonal or chemotherapy
- •Invasive lobular histology
- •Pure ductal carcinoma in situ (DCIS)
- •Diffuse suspicious microcalcifications
结局指标
主要结局
In-Breast Tumor Recurrence (IBTR)
时间窗: 5 years
Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
次要结局
- Overall Survival(5 years)
- Late Toxicity(5 years)
- Disease Free Survival(5 yeras)
- Acute Toxicity(3 months)
研究者
研究点 (1)
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