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 number | NCT00002894 |
| Secondary identifying numbers | ICON4 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 1. Survival time 2. Quality of life 3. Health economics |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/1996 |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 800 in 5 countries |
| 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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| 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 time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/06/2003 | Yes | No | |
| 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.
