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
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

Study website

Contact information

Ms Monica Verma
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleA 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 objectivesTo 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) studiedCancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)CA125 (a serum marker)
Primary outcome measureSurvival time
Secondary outcome measures1. Quality of life
2. Health Economics
Overall study start date26/05/1996
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants1400 - closed to recruitment and in long-term follow-up
Key inclusion criteria1. 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 criteriaPrevious malignancy within 5 years
Date of first enrolment26/05/1996
Date of final enrolment31/12/2005

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

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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)