Contact information
Type
Scientific
Primary contact
Mr S R Duffy
ORCID ID
Contact details
Level 9
Gledhow Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 5840
s.r.duffy@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436125539
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Endometrial cancer
Intervention
Randomised controlled trial. Random allocation to [A] Arimidex [B] placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Anastrozole (Arimidex®)
Primary outcome measures
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 trial start date
01/04/2003
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
170
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2003
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary