Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002895
Protocol/serial number
OV05
Study information
Scientific 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
Acronym
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.
Ethics approval
London MREC approval
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Cancer
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
CA125 (a serum marker)
Primary outcome measure
Survival time
Secondary outcome measures
1. Quality of life
2. Health Economics
Overall trial start date
26/05/1996
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
1400 - closed to recruitment and in long-term follow-up
Participant exclusion criteria
Previous malignancy within 5 years
Recruitment start date
26/05/1996
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Austria, Belgium, France, Ireland, Italy, Netherlands, Portugal, Russian Federation, South Africa, Spain, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20888993
Publication citations
-
Results
Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM, , , Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial., Lancet, 2010, 376, 9747, 1155-1163, doi: 10.1016/S0140-6736(10)61268-8.