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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
-
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.