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ISRCTN
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ISRCTN43987580
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DOI
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10.1186/ISRCTN43987580
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Pre-operative chemotherapy for cancer of the oesophagus
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Scientific title
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Acronym
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N/A
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Serial number at source
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OE02
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Study hypothesis
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To investigate in patients considered to have resectable cancer of the oesophagus whether pre-operative chemotherapy:
1. Prolongs survival
2. Affects physical well-being
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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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1. Tumour considered resectable
2. No evidence of cervical lymph node involvement or metastases
3. Creatinine clearance ≥60 ml/min
4. Total white blood cell count ≥3.5 x 109l
5. Platelet count ≥100 x 109l
6. No indication for urgent resection
7. No previous chemotherapy, radiotherapy or surgery for current oesophageal cancer
8. No other previous or concomitant malignant disease
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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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01/02/1992
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Anticipated end date
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30/06/1998
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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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800
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Interventions
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1. One group receives pre-operative chemotherapy followed by surgery
2. The other group = Control group receives surgery alone
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Primary outcome measure(s)
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Survival time
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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 (MRC) (UK)
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Trial website
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Publications
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2009 long term results in http://www.ncbi.nlm.nih.gov/pubmed/19770374
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Contact name
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Dr
James
Lyddiard
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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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28/02/2001
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Last edited
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22/02/2010
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Date ISRCTN assigned
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28/02/2001
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