To compare intravenous treosulphan with intravenous treosulphan plus cisplatin in advanced ovarian cancer
| ISRCTN | ISRCTN59482963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59482963 |
| Protocol serial number | O10 |
| Sponsor | Leo Pharmaceuticals |
| Funder | Leo Pharmaceuticals (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Treosulphan |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| 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
- 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 | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
