Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I/II Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity
研究概览
简要总结
This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 (36 Gy)
36 Gy in 9 fractions BID x 4 1/2 treatment days
干预措施: Partial Breast Irradiation (PBI) (Radiation)
Cohort 2 (40 Gy)
40 Gy in 10 fractions BID over 5 treatment days
干预措施: Partial Breast Irradiation (PBI) (Radiation)
结局指标
主要结局
Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity
时间窗: Within 1 year of protocol registration
-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity
Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan
时间窗: Within 1 year of protocol registration
-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
次要结局
- Local Control Rate(Up to 5 years)
- Distant Control Rate(Up to 5 years)
- Incidence and Severity of Cutaneous Toxicity(Up to 5 years)
- Incidence of Fat Necrosis(Up to 5 years)
- Incidence of Breast Fibrosis(Up to 5 years)
- Cosmetic Outcome(Up to 5 years)
- Regional Control Rate(Up to 5 years)