NCT00977275已完成1 期
The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma
研究概览
简要总结
The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.
详细描述
- When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
- The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
- •Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor < 2cm, clinically negative nodes)
- •Location of primary tumor is not immediately adjacent to the nipple of chest wall
- •No evidence of two or more separate tumors within the breast
- •All histologic types and pathologic grades of primary tumor
- •No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
- •No lymphatic or vascular invasion
- •Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed)
- •Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
- •18 years of age or older
排除标准
- •Tumor is too close to the chest wall to allow placement of catheters
- •Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
结局指标
主要结局
To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma
时间窗: 3 years
次要结局
未报告次要终点
研究者
Alphonse Taghian, MD, PhD
Chief Breast Radiation Oncology, MGH
Massachusetts General Hospital
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Partial Breast Irradiation (PBI) for Selected Patients With Early Breast CancerBreast NeoplasmsNCT00325598Washington University School of Medicine100
进行中（未招募）
不适用
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast CancerBreast CancerNCT03917498Michael Yassa20
已完成
1 期
Single Dose Partial Breast RadiotherapyBreast CancerNCT00944528Duke University35
已完成
不适用
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast CancerBreast CancerNCT00182728UNC Lineberger Comprehensive Cancer Center89
Unknown
不适用
Tumor Bed Dose Delivery Using A Breast Specific Radiosurgery Device, The Gammapod: (A Clinical Feasibility Study)Breast NeoplasmsNCT02627313Ottawa Hospital Research Institute20