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ISRCTN
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ISRCTN75843298
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ClinicalTrials.gov identifier
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Public title
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North Thames CA125 study in advanced ovarian 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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NTOG4
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Study hypothesis
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Five versus eight courses of carboplatin or cisplatin in ovarian cancer.
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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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Ovarian cancer
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Participants - inclusion criteria
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1. Histologically confirmed diagnosis of invasive epithelial ovarian carcinoma
2. International Federation of Gynaecology and Obstetrics (FIGO) stage Ic, II, III or IV
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. Aged 18 - 75 years
5. Adequate renal, hepatic and bone marrow function
6. Life expectancy of at least 3 months
7. No history of previous malignancy, except basal cell carcinoma of the skin or in situ carcinoma of the cervix
8. No medical contra-indications to protocol treatments
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Participants - exclusion criteria
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Does not comply with above inclusion criteria.
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Anticipated start date
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05/12/1989
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Anticipated end date
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13/04/1994
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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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237
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Interventions
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Patients are randomised to one of two treatment schedules:
1. Schedule A: Carboplatin or cisplatin repeated every four weeks for a total of five courses. CA125 measurement to be carried out prior to each course.
2. Schedule B: Carboplatin or cisplatin repeated every four weeks for a total of eight courses. CA125 measurement to be carried out prior to each course.
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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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Not provided at time of registration
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Trial website
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Publications
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Follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/8805927
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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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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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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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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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Date applied
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01/07/2001
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Last edited
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02/04/2008
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Date ISRCTN assigned
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01/07/2001
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