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ISRCTN
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ISRCTN52711596
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised trial of adjuvant chemotherapy in node positive early stage carcinoma of the cervix
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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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CE3005
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Study hypothesis
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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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Cervix cancer
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Participants - inclusion criteria
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1. Histologically proven invasive adeno or squamous cell carcinoma of the cervix
2. Histologically proven pelvic lymph node involvement
3. Stage Ib or IIa disease
4. Fit to receive either treatment arm
5. Adequate renal hepatic and haematological function
6. Adequate pulmonary function
7. Patients with a probability of <0.2 of not developing severe encephalopathy with ifosfamide/mensa treatment are excluded
8. No second primary tumour other than basal cell carcinoma of the skin
9. No other serious medical or psychological condition precluding treatment
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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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01/01/1990
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Anticipated end date
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28/02/1996
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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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Not provided at time of registration
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Interventions
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Following surgery patients are randomised to either:
1. Arm A: External beam pelvic radiotherapy
2. Arm B: Adjuvant chemotherapy plus external beam radiotherapy
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Primary outcome measure(s)
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Not provided at time of registration
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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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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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23/05/2008
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Date ISRCTN assigned
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01/07/2001
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