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
ISRCTN | ISRCTN87786644 |
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DOI | https://doi.org/10.1186/ISRCTN87786644 |
ClinicalTrials.gov number | NCT00002895 |
Secondary identifying numbers | OV05 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 22/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=21
Contact information
Ms Monica Verma
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Other |
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 |
Study objectives | 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(s) | London MREC approval |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | CA125 (a serum marker) |
Primary outcome measure | Survival time |
Secondary outcome measures | 1. Quality of life 2. Health Economics |
Overall study start date | 26/05/1996 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | 1400 - closed to recruitment and in long-term follow-up |
Key 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 |
Key exclusion criteria | Previous malignancy within 5 years |
Date of first enrolment | 26/05/1996 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Austria
- Belgium
- England
- France
- Ireland
- Italy
- Netherlands
- Portugal
- Russian Federation
- South Africa
- Spain
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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clinical.trial@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Plain English results | No | Yes | |||
Results article | results | 02/10/2010 | Yes | No |
Editorial Notes
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)