Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- local recurrence
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.
详细描述
OBJECTIVES:
- is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis.
- To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival.
- proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders
- quality of life
OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.
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
- 60 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 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
accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
干预措施: biopsy (Procedure)
accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
干预措施: fine-needle aspiration (Procedure)
accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
干预措施: accelerated partial breast irradiation (Radiation)
accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
干预措施: image-guided radiation therapy (Radiation)
结局指标
主要结局
local recurrence
时间窗: 5 years
Local recurrences should not exceed 4% at 5 years of follow-up
次要结局
- Pathological response(6 weeks after finishing iradiation treatment)
- breast fibrosis(5 years)
- cosmetic outcome(5 years)