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ISRCTN
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ISRCTN26689999
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ClinicalTrials.gov identifier
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Public title
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A multicentre, randomised trial of primary chemotherapy in inoperable cervical cancer
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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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CE3003
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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
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Participants - inclusion criteria
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1. Histologically proven invasive squamous cell carcinoma of the cervix uteri
2. Inoperable disease, that is stage II, III or IVA. Stage IIA disease may be included if deemed inoperable by the referring gynaecologist
3. No previous treatment for invasive cervical cancer
4. World Health Organisation (WHO) performance status >2
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. Expected survival of >3 months
9. No second primary tumour other than basal cell carcinoma of the skin
10. 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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01/01/1988
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Anticipated end date
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31/12/1995
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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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172
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Interventions
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1. Arm A: Radical pelvic radiotherapy
2. Arm B: Primary chemotherapy with bleomycin, ifosfamide and cisplatinum repeated every 28 days for two courses followed by radical pelvic radiotherapy. If after two courses of chemotherapy the measurable disease has not been reduced to <2 cm diameter and if further response is expected, then a third course of chemotherapy may be given followed by radical pelvic 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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2000 results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11061615
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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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31/01/2008
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Date ISRCTN assigned
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01/07/2001
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