NL-OMON55435已完成3 期
Pre- versus Postoperative Accelerated Partial Breast Irradiation in early stage breast cancer patients - PAPBI-2
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Female patients * 51 years
- •* cT1-2 (* 3 cm)
- •* Grade I or grade II (biopsy)
- •* Histologically proven invasive ductal adenocarcinoma
- •* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to
- •the tumor are accepted as long as it is suitable for local excision to be
- •determined by the participating centre)
- •* WHO performance * 2
- •* Life expectancy * 5 years
- •* Written informed consent
排除标准
- •* Distant metastases
- •* Lobular invasive carcinomas
- •* Pure DCIS without invasive tumor
- •* Grade III in biopsy
- •* Triple negative tumors
- •* HER2neu positive tumors
- •* Lymphvascular invasion in biopsy
- •* pN+ (Micro- or macrometastases
- •* Multicentric / multifocal disease on mammogram or MRI
- •* Diffuse calcifications on mammogram (Birads 3, 4 or 5)
- •* Prior treatment for the protocol tumor (no surgery, no neoadjuvant
- •chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)
- •* Previous contralateral breast cancer:
- •* Other neoplasms in the last 5 years with the exception of:
- •- Basal cell carcinoma of the skin
- •- Adequately treated carcinoma in situ of the cervix
- •* Planned oncoplastic resection with tissue displacement
- •* No social security affiliation/health insurance
- •* Participation in another clinical trial that interferes with the locoregional
- •treatment of this protocol
- •* It is expected that dosimetric constraints cannot be met, ie, lung/heart
- •constraints (see 6.1.5), or if the ratio PTV/ ipsilateral breast >30%
研究者
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