Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
07/07/2014
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

NCT00002894

Protocol/serial number

ICON4

Study information

Scientific title

Acronym

Study hypothesis

To compare paclitaxel combined with platinum to a control arm of conventional platinum-based chemotherapy in the treatment of women with recurrent 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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

Paclitaxel combined with platinum and the other group receives platinum-based chemotherapy (with no paclitaxel)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Survival time
2. Quality of life
3. Health economics

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/1996

Overall trial end date

31/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Recurrent epithelial ovarian cancer previously treated with chemotherapy
2. Treatment-free interval of at least 6 months

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

800 in 5 countries

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/1996

Recruitment end date

31/03/2002

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

2003 results in: http://www.ncbi.nlm.nih.gov/pubmed/12826431

Publication citations

  1. Results

    Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C, , Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial., Lancet, 2003, 361, 9375, 2099-2106.

Additional files

Editorial Notes