Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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

http://www.leo-pharma.co.uk/w-site/leo-gb/docs-gb.nsf

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

Publication citations

Additional files

Editorial Notes