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ISRCTN
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ISRCTN87786644
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DOI
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10.1186/ISRCTN87786644
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ClinicalTrials.gov identifier
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NCT00002895
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EudraCT number
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Public title
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A randomised trial in relapsed ovarian cancer, early treatment based on Cancer Antigen (CA) 125 levels alone versus delayed treatment based on conventional clinical factors
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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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OV05
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Study hypothesis
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To investigate the benefit of early chemotherapy for recurrent ovarian cancer based on a raised CA125 (a serum marker) level alone, versus chemotherapy based on conventional clinical indicators. The policies will be compared in terms of overall survival, quality of life and health economics.
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Lay summary
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http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=21
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Ethics approval
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London MREC approval
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Study design
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Randomised controlled trial
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Countries of recruitment
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Russian Federation, South Africa, United Kingdom, Europe
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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. Histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal carcinoma
2. In complete remission with a normal CA125 since first-line platinum containing chemotherapy
3. A normal CA125 result within 4 weeks of registration onto the trial
4. Patient in confirmed remission (based on physical gynaecological examination) within 6 weeks of registration onto the trial
5. Able to attend regular follow-up and have regular blood tests
6. Local laboratory able to blind CA125 results from clinicians
7. No concomitant or previous malignancy within 5 years which is likely to interfere with the protocol treatments or comparisons, except with concomitant or previous non-melanoma skin cancer
8. Informed consent from the patient
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Participants - exclusion criteria
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Previous malignancy within 5 years
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Anticipated start date
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26/05/1996
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Anticipated end date
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31/12/2005
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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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1400 - closed to recruitment and in long term follow-up
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Interventions
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Patients are initially registered onto the trial. Following a raised CA125 result patients are randomised to receive either delayed treatment until patient shows clinical signs of relapse or immediate treatment which must start within 4 weeks.
All patients will be followed until death at 3 monthly visits.
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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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1. Quality of life
2. Health Economics
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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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http://www.ctu.mrc.ac.uk/studies/documents/OV05v21.pdf
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20888993
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Contact name
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Ms
Monica
Verma
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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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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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04/08/2011
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Date ISRCTN assigned
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06/04/2000
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