To compare intravenous treosulphan with intravenous treosulphan plus cisplatin in advanced ovarian cancer
| ISRCTN | ISRCTN59482963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59482963 |
| Secondary identifying numbers | O10 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | To compare intravenous treosulphan with intravenous treosulphan plus cisplatin in advanced ovarian cancer |
| 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 | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Treosulphan |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1993 |
| Completion date | 01/08/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1993 |
| Date of final enrolment | 01/08/1995 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Leo Pharmaceuticals
Industry
Industry
Longwick Road
Princes Risborough
HP27 9RR
United Kingdom
| Phone | +44 1844 347333 |
|---|---|
| medical-info.uk@leo-pharma.com | |
| Website | http://www.leo-pharma.co.uk/w-site/leo-gb/docs-gb.nsf |
"ROR" |
https://ror.org/05tzrdd39 |
Funders
Funder type
Industry
Leo Pharmaceuticals (UK)
No information available
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 |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
