Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
09/07/2014
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 Claire Amos

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

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

Phase

Not Applicable

Drug names

Paclitaxel, carboplatin, cyclophosphamide, doxorubicin, cisplatin

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/03/1995

Overall trial end date

01/06/1998

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

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

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

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12241653

Publication citations

  1. Results

    Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial., Lancet, 2002, 360, 9332, 505-515, doi: 10.1016/S0140-6736(02)09738-6.

Additional files

Editorial Notes