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

ISRCTN	ISRCTN80827145
DOI	https://doi.org/10.1186/ISRCTN80827145
Protocol serial number	N0436125539
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr S R Duffy
Scientific

Level 9
Gledhow Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 206 5840
Email	s.r.duffy@leeds.ac.uk

Primary study design	Interventional
Study design	Randomised placebo-controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	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
Study objectives	To investigate the therapeutic effects of Arimidex in endometrial cancer. Primary objective - to assess the volume of endometrial cancer in both the Arimidex and placebo arm, and to compare the biology of the endometrial cancer in both arms.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Endometrial cancer
Intervention	Randomised controlled trial. Random allocation to [A] Arimidex [B] placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Anastrozole (Arimidex®)
Primary outcome measure(s)	1. Alteration in endometrial cancer volume as determined by MRI 2. Alteration in immumohistochemical markers of proliferation and apoptosis
Key secondary outcome measure(s)	1. Incidence of side effects 2. Number of lymph node positive cases at surgical staging
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	170
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2003
Date of final enrolment	31/07/2006

St James's University Hospital

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

19/02/2018: No publications found, verifying study status with principal investigator.
19/11/2015: no publications found on PubMed.