Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 below 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

170

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

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

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

Publication citations

Additional files

Editorial Notes

19/11/2015: no publications found on PubMed.