SB (Swedish Breast Cancer Group) 91:A Breast Conserving Surgery With or Without Postoperative Radiotherapy for Breast Cancer Stage 1-2 (<30 mm) pN0, M0
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 1,187
- 试验地点
- 1
- 主要终点
- Loco-regional recurrence
研究概览
简要总结
The main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.
详细描述
The trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. Tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. Late side effects of the treatment are studied.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •not over the age of 75 years
- •operated because of stage 1-2 invasive adenocarcinoma of the breast
- •radical excision of the tumour
排除标准
- •earlier cancer except cancer in situ of the cervix or skin
- •distant metastases
研究组 & 干预措施
postoperative radiotherapy
Patients were treated with radiotherapy to 50 Gy in 25 fractions
干预措施: postoperative radiotherapy (Radiation)
control
Patients received no further treatment after surgery
结局指标
主要结局
Loco-regional recurrence
时间窗: 35 years
Recurrence in the breast or regional lymph nodes
次要结局
- survival(35 years)
- Secondary malignancies(35 years)