A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- IORT (Intra-operative Radiation Therapy) treatment interval
研究概览
简要总结
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.
Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 50 years of age of older
- •Patient has elected breast conserving surgical treatment for early-stage breast cancer
- •Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient
- •Life expectancy of more than 2 years
- •Tumor size 4cm or less
- •Women of childbearing potential must agree to use adequate contraception
排除标准
- •Pregnant or nursing
- •Any contraindication to radiotherapy
- •Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
- •Patient meets any of the ASTRO criteria for an "unsuitable" patient
- •Patient requires chemotherapy within two weeks of IORT
- •Breast implants
- •A serious uncontrolled medical disorder
- •Significant history of uncontrolled cardiac disease or CNS disease
结局指标
主要结局
IORT (Intra-operative Radiation Therapy) treatment interval
时间窗: 90 minutes or less
Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete
Overall incidence of adverse events and major toxicities
时间窗: Up to 6 months following treatment
次要结局
- Quality of life assessment(Up to 6 months following treatment)
- Cosmetic Outcome(Up to 6 months following treatment)
- IORT treatment parameters(upto 6 hours)
研究者
Shayna Showalter, MD
Assistant Professor
University of Virginia