Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Wheeler

ORCID ID

Contact details

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

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 below to request a patient information sheet

Condition

Cancer

Intervention

One group interval debulking surgery/control

Intervention type

Other

Phase

Not Specified

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 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

Publication citations

Additional files

Editorial Notes

17/11/2015: No publications found on PubMed.