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
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

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 information

Study designRandomised placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 objectivesTo 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) studiedEndometrial cancer
InterventionRandomised controlled trial. Random allocation to [A] Arimidex [B] placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Anastrozole (Arimidex®)
Primary outcome measure1. Alteration in endometrial cancer volume as determined by MRI
2. Alteration in immumohistochemical markers of proliferation and apoptosis
Secondary outcome measures1. Incidence of side effects
2. Number of lymph node positive cases at surgical staging
Overall study start date01/04/2003
Completion date31/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants170
Key inclusion criteriaPatients 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2003
Date of final enrolment31/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St James's University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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