Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
29/08/2012
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 Sarah Wheeler

ORCID ID

Contact details

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

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 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 (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

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

  1. Poveda A, Ovarian cancer treatment: what is new., Int. J. Gynecol. Cancer, 13 Suppl 2, 241-250.

  2. Colombo N, Pecorelli S, What have we learned from ICON1 and ACTION?, Int. J. Gynecol. Cancer, 13 Suppl 2, 140-143.

  3. 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.

  4. 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.

Additional files

Editorial Notes