Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Local Disease Relapse
研究概览
简要总结
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
详细描述
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
- Local recurrence in early stage breast cancer patients treated with IORT.
- Toxicity associated with IORT.
- Long-term disease-specific and overall survival
- Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
- Quality of life in patients treated with IORT.
- Health care costs associated with IORT.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Age ≥ 45 years.
- •Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
- •Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
排除标准
- •Scleroderma, systemic sclerosis and active lupus.
- •Participation in an investigational drug or device study.
- •Previous ipsilateral radiation to the thorax or breast.
- •Multifocal breast cancer.
- •Pregnant patients.
- •Patient not competent to provide informed consent.
- •Neoadjuvant systemic therapy.
- •Lymphovascular invasion on biopsy pathology
研究组 & 干预措施
Treatment
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
干预措施: Intraoperative Radiation Therapy (Radiation)
结局指标
主要结局
Local Disease Relapse
时间窗: 10 years
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
次要结局
- Disease specific and overall survival(10 years)
研究者
Michelle Yao
MD
Benaroya Research Institute