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 |
| Secondary identifying numbers | ICON3 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Paclitaxel, carboplatin, cyclophosphamide, doxorubicin, cisplatin |
| Primary outcome measure | Survival time - time to progression, quality of life, health economics |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/03/1995 |
| Completion date | 01/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/08/2002 | Yes | No |
