A randomised trial of paclitaxel combined with platinum-based chemotherapy vs conventional platinum-based chemotherapy in the treatment of women with ovarian cancer
| ISRCTN | ISRCTN47434271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47434271 |
| ClinicalTrials.gov (NCT) | NCT00002894 |
| Protocol serial number | ICON4 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 29/10/2021
- 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 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 | A randomised trial of paclitaxel combined with platinum-based chemotherapy vs conventional platinum-based chemotherapy in the treatment of women with ovarian cancer |
| Study objectives | To compare paclitaxel combined with platinum to a control arm of conventional platinum-based chemotherapy in the treatment of women with recurrent ovarian cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | Paclitaxel combined with platinum and the other group receives platinum-based chemotherapy (with no paclitaxel) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 800 |
| Total final enrolment | 802 |
| Key inclusion criteria | 1. Recurrent epithelial ovarian cancer previously treated with chemotherapy 2. Treatment-free interval of at least 6 months |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/1996 |
| Date of final enrolment | 31/03/2002 |
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 time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/06/2003 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 08/09/2009 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
