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 (NCT)	NCT00002895
Protocol serial number	OV05
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	CA125 (a serum marker)
Primary outcome measure(s)	Survival time
Key secondary outcome measure(s)	1. Quality of life 2. Health Economics
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	1400
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/10/2010		Yes	No
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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