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
Secondary identifying numbers	N0436125539

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

Study design	Randomised placebo-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Anastrozole (Arimidex®)
Primary outcome measure	1. Alteration in endometrial cancer volume as determined by MRI 2. Alteration in immumohistochemical markers of proliferation and apoptosis
Secondary outcome measures	1. Incidence of side effects 2. Number of lymph node positive cases at surgical staging
Overall study start date	01/04/2003
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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