Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To evaluate change over time on the incidence of local and distance recurrence rates.
研究概览
简要总结
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
详细描述
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
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
- 50 Years 至 95 Years（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
- •Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more
- •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 Tis or T1 (AJCC criteria)
- •Grade 1, 2, or 3 acceptable
- •Associated LCIS is allowed
- •Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria)
- •Estrogen receptor (ER) status of positive
- •Patient has clear margins >2 mm 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
- •Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy
排除标准
- •Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- •Immunocompromised 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
- •Invasive lobular carcinoma
- •Evidence of lymphovascular invasion (LVI)
- •Invasive carcinoma with extensive intraductal component (EIC)
- •Neoadjuvant chemotherapy
- •Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
- •Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
结局指标
主要结局
To evaluate change over time on the incidence of local and distance recurrence rates.
时间窗: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
次要结局
- To evaluate changes in the short-term and long-term side effects related to IOERT(1 month, 3 months, 6 months, 12 months, and then annually for 10 years.)