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 |
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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
Scientific
Level 9
Gledhow Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Phone | +44 (0)113 206 5840 |
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s.r.duffy@leeds.ac.uk |
Study information
Study design | Randomised placebo-controlled parallel-group trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
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Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
19/02/2018: No publications found, verifying study status with principal investigator.
19/11/2015: no publications found on PubMed.