A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer

Medical Research Council (MRC) (UK)0 个研究点目标入组 2,300 人开始时间: 2000年4月6日最近更新: 2018年11月19日

适应症

试验速览

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19070889 2008 pooled trial results, systematic review and meta-analysis of STEC and NCIC CTG EN.5 trials: http://www.ncbi.nlm.nih.gov/pubmed/19070891

•Surgical randomisation inclusion:
•1. Histologically proven diagnosis of endometrial carcinoma
•2. Disease thought pre-operatively to be confined to the corpus (CT or MRI scanning suggesting node enlargement is not an exclusion to randomisation and should not influence the decision to randomise)
•3. Patient fit to undergo lymphadenectomy
•4. Centre able to offer appropriate surgery
•5. Patient fit to receive external beam radiotherapy
•6. Written informed consent (for randomisation into both surgical and radiotherapy components).
•Radiotherapy randomisation inclusion:
•1. Histologically proven diagnosis of endometrial carcinoma
•2. Disease pre-operatively confined to the corpus
•3. Macroscopically free of disease (positive para-aortic nodes should be viewed as indicative of further [unseen] macroscopic disease)
•4. Fit to receive external beam radiotherapy
•5. High risk pathology, assessed independently of nodal status, defined as one or more of the following: Grade 3 (poorly differentiated) or Invasion to the outer half of the myometrium or Serous papillary or clear cell type or Stage IIA
•6. Written informed consent.

发起方

Medical Research Council (MRC) (UK)