Submission date
28/02/2001
Registration date
28/02/2001
Last edited
09/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Ms Claire Amos

ORCID ID

Contact details

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

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

ICON3

Study information

Scientific title

Acronym

Study hypothesis

To compare paclitaxel in combination with carboplatin versus a control treatment of either single-agent carboplatin or CAP (cyclophosphamide, doxorubicin and cisplatin) as first-line treatment of patients with advanced ovarian cancer.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study 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

1. One group receives paclitaxel in combination with carboplatin
2. The other group receives a control treatment of either single-agent carboplatin or CAP (cyclophosphamide, doxorubicin and cisplatin)

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Paclitaxel, carboplatin, cyclophosphamide, doxorubicin, cisplatin

Primary outcome measure

Survival time - time to progression, quality of life, health economics

Secondary outcome measures

Not provided at time of registration

Overall study start date

27/03/1995

Overall study end date

01/06/1998

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Chemotherapy indicated
2. No previous chemotherapy or radiotherapy
3. No contraindication to chemotherapy

Participant type(s)

Patient

Age group

Not Specified

Sex

Female

Target number of participants

2000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

27/03/1995

Recruitment end date

01/06/1998

Locations

Countries of recruitment

England, United Kingdom

Study 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

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

UK Medical Research Council, MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/08/2002 Yes No

Additional files

Editorial Notes