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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
DOI 10.1186/ISRCTN87786644
ClinicalTrials.gov identifier NCT00002895
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source OV05
Study hypothesis 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.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=21
Ethics approval London MREC approval
Study design Randomised controlled trial
Countries of recruitment Austria, Belgium, France, Ireland, Italy, Netherlands, Portugal, Russian Federation, South Africa, Spain, United Kingdom
Disease/condition/study domain Cancer
Participants - inclusion criteria 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
Participants - exclusion criteria Previous malignancy within 5 years
Anticipated start date 26/05/1996
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material
Target number of participants 1400 - closed to recruitment and in long-term follow-up
Interventions 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.
Primary outcome measure(s) Survival time
Secondary outcome measure(s) 1. Quality of life
2. Health Economics
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://www.ctu.mrc.ac.uk/studies/documents/OV05v21.pdf
Publications 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20888993
Contact name Ms  Monica  Verma
  Address MRC Clinical Trials Unit
222 Euston Road
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 06/04/2000
Last edited 14/07/2014
Date ISRCTN assigned 06/04/2000
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