International Collaborative Ovarian Neoplasm studies (3): a trial of paclitaxel with carboplatin in the first-line treatment of ovarian cancer
| ISRCTN | ISRCTN57157825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57157825 |
| Protocol serial number | ICON3 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 09/07/2014
- 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 Claire Amos
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Paclitaxel, carboplatin, cyclophosphamide, doxorubicin, cisplatin |
| Primary outcome measure(s) |
Survival time - time to progression, quality of life, health economics |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 2000 |
| Key inclusion criteria | 1. Chemotherapy indicated 2. No previous chemotherapy or radiotherapy 3. No contraindication to chemotherapy |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 27/03/1995 |
| Date of final enrolment | 01/06/1998 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/08/2002 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
