A randomised, double blind trial to assess the morphological and biological effects with Arimidex, compared to placebo when used as neoadjuvant treatment for patients with endometrial cancer

INTERVENTION: Randomised controlled trial. Random allocation to [A] Arimidex [B] placebo CONDITION: Endometrial cancer ; Cancer ; Malignant neoplasm of corpus uteri PRIMARY OUTCOME: 1. Alteration in endometrial cancer volume as determined by MRI; 2. Alteration in immumohistochemical markers of proliferation and apoptosis SECONDARY OUTCOME: 1. Incidence of side effects ; 2. Number of lymph node positive cases at surgical staging INCLUSION CRITERIA: Patients for this study will be recruited form a number of selected gynaecology/oncology units in the Yorkshire Strategic Health Authority. No formal power calculation is possible as there is no information or literature in this research. An arbitrary figure of 60 patients has been chosen based on 30% accrual from the patient population. Currently 203 patients per year are registered in the Yorkshire region. Of these, 84%b undergo surgery (n = 170) and therefore eligible to participate. In order to produce more information on the Arimimdex arm the patients will be randomised on a 2:1 basis to either Arimidex or placebo.