Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Safety
研究概览
简要总结
The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.
详细描述
Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
- •T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
- •Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
- •Life expectancy > 6 months
- •Negative pregnancy test at the time of start of treatment in any female of reproductive age
排除标准
- •Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
- •Prior radiation to ipsilateral breast or regional nodes
- •Inability to receive study treatment planning and treatment secondary to body habitus
研究组 & 干预措施
A: Ipsilateral axillary node-negative breast cancer
Patients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1)
干预措施: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor (Radiation)
B: Ipsilateral axillary node-positive breast cancer
Patients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1)
干预措施: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes (Radiation)
结局指标
主要结局
Treatment Safety
时间窗: 12 months
Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0
次要结局
- Acute Toxicity(12 months)
- Late Toxicity(5 years)
- Treatment Tolerability by EORTC QLQ-C30(2 years)
- Treatment Tolerability by EORTC QLQ-BR42(2 years)
- Tumor Response Rate in the Gross Disease Volume (40Gy)(1 year)
- Progression Free Rate in the Microscopic Disease Volume (26Gy)(1 year)
- Clinical Response in patients with Palpable Disease(1 year)
研究者
Alexander Stessin
Professor, Department of Radiation Oncology
Stony Brook University