Chemotherapy with or without surgery in treating patients with stage II or III ovarian cancer

ISRCTN	ISRCTN84121653
DOI	https://doi.org/10.1186/ISRCTN84121653
ClinicalTrials.gov (NCT)	NCT00003695
Protocol serial number	OV06
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 25/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Sarah Wheeler
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised trial of interval debulking surgery in epithelial ovarian cancer suboptimally debulked at primary surgery
Study objectives	To determine the impact of interval debulking surgery in newly diagnosed ovarian cancer in patients with residual macroscopic disease after surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ovarian cancer
Intervention	One group interval debulking surgery/control
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Survival, progression-free survival and quality of life
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	26/07/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	1000
Key inclusion criteria	1. Newly diagnosed, histologically confirmed epithelial ovarian cancer 2. International Federation of Gynecology and Obstetrics (FIGO) stage II, III or IV 3. Residual macroscopic disease more than 1 cm in diameter documented at primary surgery or post-operatively by imaging 4. Patient planned to receive platinum-based chemotherapy 5. Patient fit for interval debulking surgery 6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons 7. Written informed consent
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1998
Date of final enrolment	26/07/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/01/2019: No publications found, verifying study status with prinicipal investigator
19/02/2018: No publications found, verifying study status with principal investigator.