A comparison of treosulfan and carboplatin in patients with ovarian cancer not suitable for treatment with cisplatin
| ISRCTN | ISRCTN88345833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88345833 |
| Protocol serial number | G44 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 04/01/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 | Ovarian cancer |
| Intervention | 1. Carboplatin: 6 x (glomerular filtration rate (GFR)+ 25) mg intravvenous every 28 days for six cycles 2. Treosulfan: 7 g/m2 intravenous every 28 days for six cycles |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | treosulfan and carboplatin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/07/1998 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Not considered for cisplatin ≥75 mg/m2 2. Stages Ic-IV 3. Histologically proven epithelial ovarian cancer 4. Life expectancy .3 months 5. World Health Organisation (WHO) Performance status 0-3 6. Creatinine clearance ≥20 ml/min White Blood Cell (WBC) Count ≥3.5 x 10^9/l Platelets ≥100 x 10^9/l |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1993 |
| Date of final enrolment | 15/07/1998 |
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 | 01/01/2006 | Yes | No |
