| Source of record | UK Trials |
| ISRCTN | ISRCTN59482963 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | O10 |
| Public title | To Compare Intravenous Treosulphan with Intravenous Treosulphan plus Cisplatin in Advanced Ovarian Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ovary |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. International Federation of Gynecology and Obstetrics (FIGO) stage Ic or II (except well differentiated), III or IV ovarian cancer
2. Histological confirmation of carcinoma of epithelial origin
3. Aged 75 or under
4. Life expectancy >2 months
5. No extensive prior chemotherapy (no prior treosulfan or cisplatin at all, and not more than one course of other cytotoxic treatment)
6. No radical prior radiotherapy to pelvis and/or abdomen within preceding 3 months
7. No depressed marrow function or gastro-intestinal bleeding
8. Good renal function |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 01/08/1995 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm A: Treosulphan given every 3 weeks
2. Arm B: Treosulphan plus cisplatin repeated every 3 weeks |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Leo Pharmaceuticals |
| Sponsor name | Leo Pharmaceuticals |
| Sponsor details | Longwick Road
Princes Risborough
United Kingdom
HP27 9RR |
| Sponsor telephone | +44 (0) 1844 347333 |
| Sponsor website | http://www.leo-pharma.co.uk/w-site/leo-gb/docs-gb.nsf |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59482963 |
| Date last extracted from ISRCTN register | 17/04/2008 |
