Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
23/02/2015
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

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OV3006

Study information

Scientific title

The role of radical surgery in advanced epithelial ovarian cancer

Acronym

Study hypothesis

Not provided at time of registration

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

Ovarian cancer

Intervention

Patients are randomised to one of two treatment arms:
1. Arm A: High activity platinum based chemotherapy. The recommended chemotherapy regimen is cyclophosphamide and cisplatin given for a maximum of eight cycles.
2. Arm B: Radical debulking surgery followed by chemotherapy as described above.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

31/12/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed epithelial ovarian cancer
2. Macroscopic residual disease unlikely in surgeon's opinion to be completely debulked without bowel resection or other procedures
3. No attempt to radically debulk
4. No prior chemotherapy or radiotherapy
5. No previous or concurrent malignancy other than non melanomatous skin cancer
6. No haematological or biochemical contra-indication to platinum chemotherapy
7. No contraindication to second laparotomy
8. Available to commence chemotherapy or undergo further surgery within 6 weeks of diagnostic laparotomy

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1990

Recruitment end date

31/12/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

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