TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- Local Relapse
研究概览
简要总结
This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.
详细描述
Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen (Hughes et al 2004). It has been demonstrated (Polgar et al. 2007, Vaidya et al. 2010) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of elderly patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.
Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. The expected local relapse rates are 0.5/1/1.5% after 2.5/5/7.5 years, respectively.
Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. Power calculations result in 265 patients with a calculated loss to follow-up of 20%, an alpha of 0.05 and a beta 0.1. Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cT1c cN0 cM0
- •≥ 70 years old
- •invasive-ductal histology
- •compliance
- •informed consent
排除标准
- •extensive intraductal component (EIC)
- •multifocality /-centricity
- •lymph vessel invasion (L1)
- •clinical signs of distant metastases or clinically suspicious lymph nodes
- •other histology
- •< 70 years old
- •missing informed consent or non-compliance
- •bilateral breast cancer at time of diagnosis
- •known BRACA 1/2 mutations (genetic testing not required)
研究组 & 干预措施
Intraoperative radiotherapy
single arm with intraoperative radiotherapy
干预措施: intraoperative radiotherapy (Radiation)
结局指标
主要结局
Local Relapse
时间窗: up to ten years
Rate of local relapse (within 2cm of the initial tumor bed)
次要结局
- Overall Survival(up to ten years)
- Ipsi- or Contralateral Breast Cancer(up to ten years)
- Cosmesis(up to 7.5 years)
- General and breast-specific Quality of Life after IORT(up to 10 years)
- Late toxicity after IORT(up to ten years)
研究者
Elena Sperk, MD
Managing Director Mannheim Cancer Center Clinical Trials Unit
Heidelberg University