NL-OMON55797
招募中
3 期
SUPREMO (Selective Use of Postoperative Radiotherapy AftEr MastectOmy). A phase III randomised trial to assess the role of adjuvant chest wall irradiation in *intermediate risk* operable breast cancer following mastectomy. - SUPREMO
EORTC European Organisation for Research and Treatment of Cancer0 个研究点目标入组 275 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- breast cancer
- 发起方
- EORTC European Organisation for Research and Treatment of Cancer
- 入组人数
- 275
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. 1 Stage II histologically confirmed unilateral breast cancer following
- •mastectomy including the following pTNM stages:
- •\-pT1, pN1, M0
- •\-pT2, pN1, M0
- •\-pT2, pN0 if grade III histology and/or lymphovascular invasion.
- •If the tumour area comprises multiple small adjacent foci of invasive carcinoma
- •then overall maximum dimension taken to determine the T staging. Multifocal or
- •multicentric tumours can be included. The size of the largest tumour determines
- •the T stage classification.
- •1\.2 Stage II histologically confirmed unilateral breast cancer following
排除标准
- •1\. Any pT0pN0\-1,or pT1pN0 tumours after primary surgery.
- •2\. Any pT3pN1 or pT4 tumours. Initial stage cT3cN1 or pN1(sn) or cT4 in
- •patients receiving neoadjuvant systemic therapy cannot be included, even if
- •downstaging has occured and the pathological ypT and N stage is lower.
- •3\. Patients who have 4 or more pathologically involved axillary nodes. For the
- •purpose of this study protocol, nodal scaring after neoadjuvant systemic
- •therapy will be considered as evidence of previous pathological nodal
- •involvement and count towards the total number of involved axillary nodes.
- •4\. Past history or current diagnosis of ductal carcinoma in situ (DCIS) of the
- •contralateral breast, unless treated by mastectomy. Previous DCIS of the
结局指标
主要结局
未指定
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