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临床试验/NCT06637202
NCT06637202进行中(未招募)不适用

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

Region Skane1 个研究点 分布在 1 个国家目标入组 1,187 人开始时间: 1991年1月1日最近更新:
适应症

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

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

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)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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