A randomised prospective phase III comparison of paclitaxel - carboplatin versus docetaxel - carboplatin as first line chemotherapy in stage Ic-IV epithelial ovarian cancer
| ISRCTN | ISRCTN31374767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31374767 |
| ClinicalTrials.gov (NCT) | NCT00003998 |
| Protocol serial number | G57 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK, Rhone-Poulenc Rorer |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 04/01/2012
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
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 |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovary |
| Intervention | 1. Docetaxel 75 mg/m(2) + Carboplatin AUC repeated on day 22 for six cycles 2. Paclitaxel 175 mg/m(2) + Carboplatin AUC 5 repeated on day 22 for six cycles |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | carboplatin versus docetaxel |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Key inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer 2. Female 3. At least 18 years old 4. Stage Ic-IV disease 5. Written informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 01/05/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/11/2004 | Yes | No |
