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ISRCTN
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ISRCTN11916376
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DOI
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10.1186/ISRCTN11916376
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ClinicalTrials.gov identifier
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NCT00002477
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EudraCT number
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Public title
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International Collaborative Ovarian Neoplasm studies (1): A trial of adjuvant chemotherapy for early stage ovarian cancer
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Scientific title
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Acronym
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ICON1
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Serial number at source
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ICON1
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Study hypothesis
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Currently it is not known whether adjuvant chemotherapy is of any benefit in ovarian cancer, and all previous trials have been too small to give reliable evidence. The prognosis for early disease is much better than for advanced disease, which is known to respond to platinum-based chemotherapy, and a similar response in early disease would prolong the lives of many thousands of women each year. However, any benefit must be weighed against the toxicity associated with the treatment employed, and hence reliable evidence regarding the size of any benefit to adjuvant treatment is needed.
The aim of the study was to compare immediate with deferred chemotherapy in patients with early stage epithelial ovarian cancer
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Lay summary
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Not provided at time of registration
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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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1. Chemotherapy not clearly indicated
2. No previous malignancy
3. No prior radiotherapy or chemotherapy
4. No contraindication to chemotherapy
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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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01/01/1991
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Anticipated end date
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21/01/2000
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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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2000
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Interventions
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Immediate chemotherapy or chemotherapy deferred until indicated
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Primary outcome measure(s)
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Survival time; recurrence-free survival.
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Secondary outcome measure(s)
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Not provided at time of registration
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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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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14656286
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14656270
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12529343
4. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11488997
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Contact name
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Ms
Sarah
Wheeler
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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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Email
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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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29/08/2012
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Date ISRCTN assigned
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06/04/2000
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