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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Ms Monica Verma
Scientific

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

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

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

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

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	02/10/2010		Yes	No

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)