International Collaborative Ovarian Neoplasm studies (1): A trial of adjuvant chemotherapy for early-stage ovarian cancer

ISRCTN	ISRCTN11916376
DOI	https://doi.org/10.1186/ISRCTN11916376
ClinicalTrials.gov number	NCT00002477
Secondary identifying numbers	ICON1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Sarah Wheeler
Scientific

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

Email	abc@email.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	International Collaborative Ovarian Neoplasm studies 1 (ICON1): A trial of adjuvant chemotherapy for early-stage ovarian cancer
Study acronym	ICON1
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer
Intervention	Immediate chemotherapy or chemotherapy deferred until indicated
Intervention type	Other
Primary outcome measure	Survival time; recurrence-free survival.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1991
Completion date	21/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	2000
Total final enrolment	477
Key inclusion criteria	1. Chemotherapy not clearly indicated 2. No previous malignancy 3. No prior radiotherapy or chemotherapy 4. No contraindication to chemotherapy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1991
Date of final enrolment	21/01/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications		01/11/2001		Yes	No
Other publications		15/01/2003		Yes	No
Other publications		01/11/2003		Yes	No
Other publications		01/11/2003		Yes	No
Abstract results	Long-term follow-up	20/06/2007	31/12/2021	No	No

31/12/2021: Abstract added.