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 measure
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 (if study stopped)
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 (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
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
Basic results (scientific)
Publication list
2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12241653
Publication citations
-
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.