NCT02370797进行中（未招募）不适用
Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
Avera McKennan Hospital & University Health Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients who are free of breast cancer.
研究概览
简要总结
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
详细描述
See points VIII inclusion/exclusion criteria
Operation:
- Lumpectomy, steninal node biopsy
- IOeRT
After Surgery:
- Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
- Chemotherapy (if indicated)
- Hormone therapy (if indicated)
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- •Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- •Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months.
- •BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- •Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
- •Grade 1, 2 acceptable
- •Associated LCIS is allowed
- •Estrogen receptor (ER) status of positive
- •Negative margins at ink on gross pathologic examination
- •Patient is node-negative, defined as N0 (i-) or N0 (i+)
- •Patient must be deemed functionally and mentally competent to understand and sign the informed consent
排除标准
- •Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- •Immuno-compromised status
- •Pregnancy
- •Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- •Breast cancer that involves the skin or chest wall, locally advanced breast cancer
- •Pure DCIS, all grades
- •Invasive lobular carcinoma
- •Evidence of lymphovascular invasion (LVI)
- •Invasive carcinoma with extensive intraductal component (EIC)
- •Neoadjuvant chemotherapy indicated
- •Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
- •Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
- •Estrogen receptor negative
- •Her2 positive
结局指标
主要结局
Proportion of patients who are free of breast cancer.
时间窗: 10 years
Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
次要结局
- Local recurrance rate with acute toxicity and cosmetic evaluations(10 years)
研究者
研究点 (2)
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