Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003695
Protocol/serial number
OV06
Study information
Scientific title
A randomised trial of interval debulking surgery in epithelial ovarian cancer suboptimally debulked at primary surgery
Acronym
Study hypothesis
To determine the impact of interval debulking surgery in newly diagnosed ovarian cancer in patients with residual macroscopic disease after surgery.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Ovarian cancer
Intervention
One group interval debulking surgery/control
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Survival, progression-free survival and quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1998
Overall trial end date
26/07/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
1000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1998
Recruitment end date
26/07/2001
Locations
Countries of recruitment
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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