ISRCTN61145589已完成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
niversity of Edinburgh, Lothian Health Board and the Common Services Agency (UK)0 个研究点目标入组 1,688 人开始时间: 2005年7月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,688
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30337220 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 21/01/2013:
- •1.1 Stage II histologically confirmed unilateral breast cancer following mastectomy including the following pTNM stages:
- •?pT2N0M0 if grade III histology and/or lymphovascular invasion
- •If the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension is taken to determine the size for T staging (see section 7.2.2 for a more detailed explanation). Multifocal or multicentric tumours can be included (pT1m; pT2m; pT3m). The size of the largest tumour focus determines the T stage classification. See section 7.2.1).
- •1.2 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:
- •?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, if the original clinical stage was cT3N0.
- •?ypT3N0M0, if original clinical staging was cT1-3cN0 M0 or cT1-3pN0 (sn) M0.
- •1.3 Unilateral invasive breast cancer that conforms to the initial clinical staging of criterion 1, but has been down-staged by neoadjuvant systemic therapy to ypT0 pN0 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.
- •2. Undergone total mastectomy (with minimum of 1 mm clear margin of invasive cancer and DCIS) and axillary staging procedure.
- •3.1 If axillary node positive (1-3 positive nodes [including micrometastases >0.2mm-=2mm]) then an axillary node clearance (minimum of 8 nodes removed) should have been performed. Isolated tumour cells do not count as micrometastases.
- •3.2 Axillary node negative 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 axillary lymph nodes. If not biopsied, internal mammary chain sentinel nodes are considered tumour negative for staging.
- •3.4 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 or neoadjuvant chemotherapy (if indicated), adjuvant or neoadjuvant endocrine therapy (if indicated) and postoperative ir
排除标准
- •Current exclusion criteria as of 21/01/2013:
- •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.
- •Previous exclusion criteria until 21/01/2013:
- •1. Undergone neoadjuvant systemic therapy
- •2. Previous or concurrent malignancy
- •3. Male sex
- •4. Pregnancy
- •5. Bilateral breast cancer
- •6. Known BCRA1 and BCRA2 carriers
研究者
相似试验
终止
3 期
HYMN: a trial comparing hyperthermia and mitomycin chemotherapy with a second BCG treatment, or other standard treatment, for bladder cancer that has come backCancerISRCTN85785327niversity College London (UK)242
已完成
3 期
Clinical trial to assess the importance of nephrectomyMetastatic renal cell carcinoma, clear cell carcinoma (the most common type of renal cell carcinoma).Malignant neoplasm of kidney, except renal pelvisCancerISRCTN19562321HS Greater Glagsow and Clyde (UK)450
已完成
3 期
A phase III, randomised, controlled trial for the treatment of HIV-associated cryptococcal meningitis: oral fluconazole plus flucytosine or one week amphotericin B-based therapy vs two weeks amphotericin B-based therapyISRCTN45035509St George's University of London (UK)680
已完成
3 期
CLEOPATRA study: the clinical efficacy and safety of light-masks at preventing dark adaptation in the treatment of non-centre-involving diabetic macular oedemaTopic: Diabetes Research Network, EyeSubtopic: Both, Other, Eye (all Subtopics)Disease: Retinopathy, Diabetic Control, Other, Retina (including diabetes)Nutritional, Metabolic, EndocrineISRCTN85596558Moorfields Eye Hospital NHS Foundation Trust (UK)300
已完成
3 期
A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)Active pulmonary tuberculosis.Infections and InfestationsTuberculosisISRCTN49676555Sequella Inc (USA)512