Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
O10
Study information
Scientific title
To Compare Intravenous Treosulphan with Intravenous Treosulphan plus Cisplatin in Advanced Ovarian Cancer
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Treosulphan
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1993
Overall trial end date
01/08/1995
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1993
Recruitment end date
01/08/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Leo Pharmaceuticals
Sponsor details
Longwick Road
Princes Risborough
HP27 9RR
United Kingdom
+44 1844 347333
medical-info.uk@leo-pharma.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Leo Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary