Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Rate of local recurrence
研究概览
简要总结
The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.
详细描述
With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed DCIS of the breast
- •Clinical ≤ 3.0 cm unifocal lesion
- •No clinical or pathological evidence of nodal involvement
- •Operable DCIS, suitable for breast conserving surgery
- •Plans to administer irradiation to the breast only
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
- •Must have had a diagnostic mammogram or MRI performed within last 6 months
- •Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines
- •Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period.
- •English or Spanish speaking
- •Able to sign informed consent
- •Amenable to regular follow-up (according to research policies) for at least 5 years.
排除标准
- •Histologic or clinical evidence of invasive breast cancer
- •Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
- •Synchronous bilateral breast cancer at the time of diagnosis
- •Pathologic or imaging evidence of lymph node involvement
- •Any severe concomitant disease that may limit their life expectancy to less than 5 years.
- •Prior history of breast cancer or in-field radiation in the ipsilateral breast.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breast feeding women
结局指标
主要结局
Rate of local recurrence
时间窗: 5 years
Defined by ipsilateral breast tumor recurrence
次要结局
- Overall survival(5 years)
- Acute Toxicities associated with IORT(6 months)
- Disease-free survival(5 years)
- Longterm radiation toxicity(5 years)
研究者
Eileen Connolly
Assistant Professor
Columbia University