ACTRN12612000407897进行中（未招募）3 期
SUPREMO, an MRC phase III randomised trial to assess the role of adjuvant chest wall irradiation in 'intermediate risk' operable breast cancer following mastectomy (TROG (Trans Tasman Radiation Oncology Group) 11.01)
nited Kingdom (UK) Medical Research Council (MRC)0 个研究点目标入组 1,600 人开始时间: 2012年4月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •1. Stage II histologically confirmed unilateral breast cancer following mastectomy including the following pTNM stages:
- •- pT2N0M0 if grade III histology and/or lymphovascular invasion
- •- pT3N0M0.
- •2. Stage II histologically confirmed unilateral breast cancer following neoadjuvant systemic therapy and mastectomy, if the original clinical stage was cT1-2cN0-1M0 or cT1-2pN1(sn)M0 and with the following (ypTNM) stages after neoadjuvant systemic therapy:
- •- ypT1pN1M0
- •- ypT2pN1M0
- •- ypT2pN0M0 if grade III histology and/or lymphovascular invasion
- •- ypT0pN0 or ypT1pN0 or ypT0pN1 (pathological complete remission, or near complete remission).
- •- ypT2N0, independent of grade or lymphovascular invasion, of the original stage was cT3N0.
- •- ypT3N0M0, if original clinical staging was cT1-3cN0 M0 or cT1-3pN0 (sn) M0.
- •3. Unilateral invasive breast cancer that conforms to the initial clinical staging of criterion 1, but has been down-staged by neoadjuvant systemic therapy to ypT0pN0 or ypT1pN0 or ypT0pN1 (pathological complete remission, or near complete remission). If tumour stage cT3 or ypT3, then nodal status must be N0 both before and after neoadjuvant systemic therapy.
- •4. Undergone total mastectomy (with minimum of 1 mm clear margin of invasive cancer and DCIS) and axillary staging procedure.
- •5. If axillary node positive (1-3 positive nodes [including micrometastases >0.2mm less than or equal to 2mm]) then an axillary node clearance (minimum of 8 nodes removed) should have been performed. Isolated tumour cells do not count as micrometastases.
- •6. Axillary node negative status can be determined on the basis of either axillary clearance or axillary node sampling or sentinel node biopsy. Positive or negative nodes should be determined before the commencement of neoadjuvant systemic therapy.
- •7. 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 axillary lymph nodes. If not biopsied, internal mammary chain sentinel nodes are considered tumour negative for staging.
- •8. Before neoadjuvant systemic therapy, axillary ultrasound is advised
- •9. Fit for adjuvant or neoadjuvant chemotherapy (if indicated), adjuvant or neoadjuvant endocrine therapy (if indicated) and postoperative irradiation.
- •10. Written, informed consent.
- •11. Patients undergoing immediate breast reconstruction are eligible for inclusion.
- •12. Patients who are carriers of known pathological mutations in BRCA1 or BRCA2 genes are eligible
- •Neoadjuvant systemic therapy:
- •- Patients who have undergone mastectomy after neoadjuvant systemic therapy are eligible.
- •- Tumour grade, hormone receptor status and Her-2 receptor status (or HER gene amplification) should be determined on a core biopsy taken before the start of neoadjuvant systemic therapy. Lymphovascular invasion may be assessed on both the core biopsy and post treatment excision.
- •- T2 tumours that are cN0 and remain ypN0 after neoadjuvant systemic therapy can only be included if grade III histology and / or lymphovascular invasion.
- •T3 tumours can only be included if N0 both before and after neoadjuvant systemic therapy (cN0, pN0(sn), ypN0).
排除标准
- •Exclusion criteria (patients who fulfill the following are NOT eligible for this study):
- •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 occurred 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 scarring 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 concurrent 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.
- •8. Pregnancy, at the time of radiotherapy treatment
- •9. Not fit for surgery, radiotherapy or adjuvant systemic therapy.
- •10. Unable or unwilling to give informed consent.
研究者
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