Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer
详细描述
OBJECTIVES:
- Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
- Determine the local recurrence rates in patients treated with this regimen.
- Determine the cosmetic outcome in patients treated with this regimen.
OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
时间窗: Patients are followed at 1 month and then every 3 months for 2 years
次要结局
未报告次要终点