RAD 1802: A Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0
研究概览
简要总结
This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
详细描述
This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
- •Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.
- •Estrogen receptor (ER) positive (>10%).
- •Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
- •Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
- •Zubrod Performance Status 0-2.
排除标准
- •Multifocal or multicentric cancer.
- •Reception of neoadjuvant chemotherapy.
- •Pure invasive lobular histology.
- •Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
- •Measured maximum PTV of >124cc.
- •Lumpectomy cavity within 5mm of body contour.
结局指标
主要结局
Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0
时间窗: 0-2 years
To determine the safety of 5 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.
次要结局
- Toxicity of breast SBRT using CTCAE v4.0(0-2 years)
- Cosmetic outcome baseline and post-SBRT(0-2 years)
- Patient reported outcome baseline and post-SBRT(0-2 years)
研究者
Drexell Hunter Boggs
Radiation Oncologist
University of Alabama at Birmingham