NCT00909909进行中（未招募）2 期
Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
- To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
Secondary
- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
- To identify co-variates responsible for poor cosmetic outcome in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
时间窗: 5 years
次要结局
- Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0(5 years)
- Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale(5 years)
研究者
Bruce G Haffty
Professor and Chairman, Department of Radiation Oncology
Rutgers, The State University of New Jersey
研究点 (6)
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