Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- Cosmetic outcome
研究概览
简要总结
Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.
详细描述
Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥ 51 years
- •clinical stage tumor-1-2 (≤ 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)
- •World Health Organization performance status ≤ 2
- •Life expectancy ≥ 5 years
- •Written informed consent
排除标准
- •Distant metastases
- •Lobular invasive carcinomas
- •Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
- •Grade III in biopsy
- •Triple negative tumors
- •HER2neu positive tumors
- •Lymphvascular invasion in biopsy
- •TNM pathologic stage N1-3
- •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 or if the ratio PTV/ipsilateral breast >30%
结局指标
主要结局
Cosmetic outcome
时间窗: 3 years
cosmetic effect will be measured by comparing the treated breast with the contralateral breast. Cosmetic effect will be scored in three different ways: by digital photographs, patient's questionnaires and specialist's questionnaires. These data will result in an overall cosmetic outcome, scored as excellent, good, fair or poor.
次要结局
- postoperative complications(6 weeks)
- tumor response(6 weeks)