Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.
详细描述
This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.
Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
- •Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- •Clinical T1N0M0
- •55 years of age or older
- •Estrogen receptor (ER) positive,
- •No evidence of lymphovascular space invasion on initial biopsy
- •Not pregnant. If not post-menopausal must adhere to birth control measures
- •White blood cell count > 3000, Hemoglobin > 9, platelets >100000
- •Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min
排除标准
- •Neoadjuvant chemotherapy
- •Breast implants
- •Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- •Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- •HER-2/neu positive
- •Positive serum pregnancy test
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 30 days
As measured by the incidence of acute toxicity and wound healing complications
次要结局
- Local Control(3 years)
- Cosmetic Outcome(3 years)