ISRCTN13672866已完成3 期
A phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)0 个研究点目标入组 600 人开始时间: 2010年4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
- 600
研究概览
简要总结
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23522754 (added 10/09/2019) 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25439688 2015 results (Dutch) in: https://www.ncbi.nlm.nih.gov/pubmed/26488192 (added 10/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Invasive breast cancer proven by core biopsy or 'triple diagnosis': clinical palpation concordant with malignancy, imaging (mammography or ultrasound) and tumour positive FNA cytology; diagnosis by excisional tumourectomy is allowed. Clinically occult invasive cancer should be proven by histology.
- •2. Tumour larger than 5 and smaller than 30 mm in its largest diameter, measured by mammography or ultrasound, only one tumour site (palpation, mammogram or ultrasound) in one breast: bilateral unifocal invasive breast cancer is allowed, (bilateral mammogram is mandatory)
- •3. Clinically negative axillary lymph nodes
- •4. Patient has to be fit to undergo any of the following treatments: SN-biopsy, axillary clearance, breast surgery, radiation therapy of the axilla
- •5. Before patient registration/randomisation, informed consent must be obtained according to ICH/EU GCP, and national/local regulations
- •6. Female, all ages considered
- •7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •8. No metastatic disease (routine investigations are not required: symptoms should be investigated on indication)
- •9. No previous treatment of the axilla by surgery or radiotherapy
- •10. No previous treatment of cancer, except Basal Cell Carcinoma of the skin and in situ carcinoma of the cervix
- •11. No pregnancy
排除标准
- •Does not meet inclusion criteria
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
招募中
不适用
BOOG 2013-07: The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy.breast neoplasmsaxillary lymph node dessctionmastectomy.breast cancerNL-OMON29048Pink Ribbon, KWF, CZ878
已完成
3 期
A phase III clinical study to compare the combination therapy of eribulin mesylate + trastuzumab + pertuzumab with paclitaxel or Docetaxel + trastuzumab + pertuzumabJPRN-UMIN000027938Japan Breast Cancer Research Group446
进行中（未招募）
3 期
JBCRG-M06(EMERALD)HER2-positive progressive-recurrent breast cancerJPRN-jRCTs021180027Yamashita Toshinari480
已完成
3 期
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study OneMultiple sclerosisNervous System DiseasesISRCTN21534255Genzyme Corporation (USA)581