NCT00138814Unknown3 期
A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost
St George Hospital, Australia6 个研究点 分布在 1 个国家目标入组 680 人开始时间: 1997年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 680
- 试验地点
- 6
- 主要终点
- Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
研究概览
简要总结
This is a two arm randomized study for patients who are undergoing radiotherapy following breast conservation surgery for breast cancer. Local recurrence of breast cancer will be compared for patients receiving boost or no boost radiotherapy.
详细描述
A boost dose of radiation is commonly but not universally employed in breast conservation techniques.
The potential disadvantages when a boost is employed include:
- Increased complexity of treatment
- Increased duration of treatment
- Increased travel, social/employment dislocation
- Increased complications
- Worse cosmesis and/or increased breast discomfort
- Increased difficulty in detecting recurrence.
- Prolongation of gap or increased delay for chemotherapy if indicated
The potential advantages of a boost are the following:
- Reduced local failure rates
- Reduced local failure translating to improved survival
- Maximising cosmesis by reducing dose to larger breast volume
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
- •Histologically proven carcinoma of the breast, T1-2 (0-5cm) N0-1, M
- •Pure ductal carcinoma in situ accepted if completely excised.
- •Any receptor status.
- •Extensive intraductal cancer (EIC) accepted if completely excised.
排除标准
- •Unable to consent
- •Vascular/collagen disorder
- •Prior malignancy except minor skin squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix .
- •Gross multifocal disease
- •Involvement of margins.
- •Bilateral breast cancer
结局指标
主要结局
Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
次要结局
- Local control translating to survival over 10 year median follow-up
- Quality of life at yearly intervals with reference to baseline
- Breast cosmesis - patient assessment and photos
研究者
研究点 (6)
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