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ISRCTN
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ISRCTN16571884
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DOI
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10.1186/ISRCTN16571884
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ClinicalTrials.gov identifier
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NCT00003749
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EudraCT number
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Public title
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A randomised trial of lymphadenectomy and of adjuvant external beam radiotherapy in endometrial cancer
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Scientific title
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Acronym
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ASTEC
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Serial number at source
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UT01
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Study hypothesis
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1. To determine the benefit or otherwise of lymphadenectomy in patients with endometrial cancer (thought pre-operatively to be confined to the corpus).
2. To determine the benefit or otherwise of post-operative adjuvant radiotherapy in patients with endometrial cancer, high risk pathology and no macroscopic disease following surgery
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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Surgical randomisation inclusion:
1. Histologically proven diagnosis of endometrial carcinoma
2. Disease thought pre-operatively to be confined to the corpus (CT or MRI scanning suggesting node enlargement is not an exclusion to randomisation and should not influence the decision to randomise)
3. Patient fit to undergo lymphadenectomy
4. Centre able to offer appropriate surgery
5. Patient fit to receive external beam radiotherapy
6. Written informed consent (for randomisation into both surgical and radiotherapy components).
Radiotherapy randomisation inclusion:
1. Histologically proven diagnosis of endometrial carcinoma
2. Disease pre-operatively confined to the corpus
3. Macroscopically free of disease (positive para-aortic nodes should be viewed as indicative of further [unseen] macroscopic disease)
4. Fit to receive external beam radiotherapy
5. High risk pathology, assessed independently of nodal status, defined as one or more of the following: Grade 3 (poorly differentiated) or Invasion to the outer half of the myometrium or Serous papillary or clear cell type or Stage IIA
6. Written informed consent.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1998
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Anticipated end date
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01/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2,300
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Interventions
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There are four groups:
1. The first group receives standard surgery alone.
2. The second group receives standard surgery plus lymphadenectomy
3. The third group receives standard surgery plus (external beam) radiotherapy
4. The fourth group receives standard surgery plus lymphadenectomy plus (external beam) radiotherapy.
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Primary outcome measure(s)
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Primary endpoint is survival.
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Secondary outcome measure(s)
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Secondary endpoints are recurrence-free survival and quality of life.
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Sources of funding
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Medical Research Council (UK)
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Trial website
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http://www.ctu.mrc.ac.uk/studies/ASTEC.asp
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19070889
2008 pooled trial results, systematic review and meta-analysis of STEC and NCIC CTG EN.5 trials: http://www.ncbi.nlm.nih.gov/pubmed/19070891
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Contact name
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Ms
Claire
Amos
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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12/01/2009
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Date ISRCTN assigned
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06/04/2000
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