NCT01185145Unknown2 期
A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 291
- 试验地点
- 12
- 主要终点
- Overall Survival
研究概览
简要总结
Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a Tis, T1, N0, M0 AJC Classification
- •Have negative surgical margins (> or = 2 mm) after final surgery
- •Should have adequate skin spacing between balloon surface and surface the skin (> 7 mm)*
- •Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
- •Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.
排除标准
- •Be pregnant or breast-feeding
- •Have collagen-vascular disease
- •Inadequate surgical margins (< 2 mm)
- •Patients with malignant/suspicious calcifications
结局指标
主要结局
Overall Survival
时间窗: 2-15 years
Ipsilateral breast failure
时间窗: 2-15 years
Disease free survival
时间窗: 2-15 years
Cause specific survival
时间窗: 2-15 years
次要结局
- Serious Adverse device-related Events(2-5 years)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Randomized Trial of Accelerated Partial Breast IrradiationBreast NeoplasmsNeoplasm Recurrence, LocalNCT03583619Cancer Institute and Hospital, Chinese Academy of Medical Sciences140
进行中（未招募）
不适用
Accelerated Partial Breast Irradiation With IMRT in Early Breast CancerBreast NeoplasmsNeoplasm Recurrence, LocalNCT03583580Cancer Institute and Hospital, Chinese Academy of Medical Sciences537
Unknown
2 期
Accelerated Partial Breast Irradiation With 3D-CRT and IMRTRadiation ToxicitySide EffectsBreast CancerNCT02003560National Institute of Oncology, Hungary90
终止
2 期
Partial Breast Irradiation Using Accelerated Intensity Modulated RadiotherapyBreast CancerNCT00581529University of Michigan Rogel Cancer Center34
已完成
2 期
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After SurgeryDuctal Breast Carcinoma In SituEstrogen Receptor PositiveInvasive Breast CarcinomaProgesterone Receptor PositiveStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerNCT02526498Rutgers, The State University of New Jersey200