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 (NCT) | NCT00002477 |
| Protocol serial number | ICON1 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 31/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Sarah Wheeler
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Survival time; recurrence-free survival. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 21/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Long-term follow-up | 20/06/2007 | 31/12/2021 | No | No |
| 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 |
Editorial Notes
31/12/2021: Abstract added.
