Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002477
Protocol/serial number
ICON1
Study information
Scientific title
Acronym
ICON1
Study hypothesis
Currently it is not known whether adjuvant chemotherapy is of any benefit in ovarian cancer, and all previous trials have been too small to give reliable evidence. The prognosis for early disease is much better than for advanced disease, which is known to respond to platinum-based chemotherapy, and a similar response in early disease would prolong the lives of many thousands of women each year. However, any benefit must be weighed against the toxicity associated with the treatment employed, and hence reliable evidence regarding the size of any benefit to adjuvant treatment is needed.
The aim of the study was to compare immediate with deferred chemotherapy in patients with early stage epithelial 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
Condition
Cancer
Intervention
Immediate chemotherapy or chemotherapy deferred until indicated
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Survival time; recurrence-free survival.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1991
Overall trial end date
21/01/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chemotherapy not clearly indicated
2. No previous malignancy
3. No prior radiotherapy or chemotherapy
4. No contraindication to chemotherapy
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
2000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1991
Recruitment end date
21/01/2000
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 (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
Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14656286
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14656270
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12529343
4. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11488997
Publication citations
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Poveda A, Ovarian cancer treatment: what is new., Int. J. Gynecol. Cancer, 13 Suppl 2, 241-250.
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Colombo N, Pecorelli S, What have we learned from ICON1 and ACTION?, Int. J. Gynecol. Cancer, 13 Suppl 2, 140-143.
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Trimbos JB, Parmar M, Vergote I, Guthrie D, Bolis G, Colombo N, Vermorken JB, Torri V, Mangioni C, Pecorelli S, Lissoni A, Swart AM, , , International Collaborative Ovarian Neoplasm trial 1 and Adjuvant ChemoTherapy In Ovarian Neoplasm trial: two parallel randomized phase III trials of adjuvant chemotherapy in patients with early-stage ovarian carcinoma., J. Natl. Cancer Inst., 2003, 95, 2, 105-112.
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Favalli G, Odicino F, Torri V, Pecorelli S, Early stage ovarian cancer: the Italian contribution to clinical research. An update., Int. J. Gynecol. Cancer, 2001, 11 Suppl 1, 12-19.