Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Monica Verma

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002895

Protocol/serial number

OV05

Study information

Scientific title

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20888993

Publication citations

  1. 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.

Additional files

Editorial Notes