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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 275
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 64（—）
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
- •neoadjuvant systemic therapy and mastectomy, if the original clinical stage was
- •cT1-2cN0-1 or cT1-2pN1(sn)M0 and with the following (ypTNM) stages after
- •neoadjuvant systemic therapy:
- •- ypT1N1M0
- •- ypT2pN1M0
- •- ypT2pN0M0 if grade III histology and/or lyphovascular invasion
- •- ypT0pN0 or ypT1pN0 or ypT0pN1 9pathological complete remission or near
- •complete remission)
- •-ypT2N0, independant of grade or lymphovascular invasion, if the priginal stage
- •-ypT3N0M0, if the original clinical staging was cT1-3cN0M0 or cT1-3pN0 (sn) M0,
- •1.3 Unilateral invasive breast cancer that conforms to the initial clinical
- •staging of criterion 1, but has been downstaged by neoadjuvant systemic therapy
- •to ypT0N0 or ypT1pN0 or ypT0N1 (pathological complete remission or near
- •complete remission). If the tumour stage cT3 or ypT3, then nodal status must be
- •N0 both before ans after neoadjuvant systemic therapy., 2. Undergone total
- •mastectomy (with minimum of 1 mm clear margin of invasive cancer and DCIS) and
- •axillary staging procedure., 3.1 If axillarynode positive (1-3 positive
- •nodes[including micrometastases >0.2 mm->= 2mm]) then an axillary node
- •clearance (minimum 8 nodes removed) should have been performed. Isolated tumour
- •cells do not count as micrometastases., 3.2 Axillary node status can be
- •determined on the basis of either axillary clearance or axillary node sampling
- •or sentinel node biopsy., 3.3 Sentinel nodes identified in the internal mammary
- •chain are considered pN1b or pN1c if histologically proven. Patients can be
- •included in the trial with microscopic metastasis in the internal mammary chain
- •detected by sentinel node biopsy, if not more than 3 tumour positive nodes in
- •axillaey lymph nodes. If not biopsied, internal mammary chain sentinel nodes
- •are considered tumour negative for staging., 3.5 Before neoadjuvant systemic
- •therapy, axillary ultrasound is advised. Abnormal axillary nodes based on
- •imaging (mammogram or ultrasound) should be sampled by guided needle sampling
- •or core biopsy. Where axillary ultrasound is normal, negative axillary node
- •status does not require histological confirmation before starting neoadjuvant
- •systemic therapy. Positive, or negative, nodal status may also be determined by
- •sentinel node biopsy before start of neoadjuvant therapy.
- •4. Fit for adjuvant chemotherapy (if indicated), adjuvant endocrine therapy (if
- •indicated) and postoperative irradiation.
- •axillary node sampling or sentinel node biopsy.
- •5. Written, informed consent.
- •NB Patients undergoing immediate breast reconstruction are eligible for
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
- •ipsilateral breast if treated with radiotherapy (i.e. previous DCIS treated by
- •conservation surgery not followed by radiotherapy would be considered eligible.)
- •5. Bilateral breast cancer. However, patients who have undergone a prophylactic
- •contralateral mastectomy can be included, if the breast was pathologically free
- •of invasive tumour.
- •6. Previous or concurrent malignancy other than non melanomatous skin cancer
- •and carcinoma in situ of the cervix. For previous DCIS see criterion 4., 7.
- •Male , 8. Pregnancy, at the time of radiotherapy treatment., 9. Not fit for
- •surgery, radiotherapy or adjuvant systemic therapy, 10. Unwilling or unable to
- •give informed consent.
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