A comparison of treosulfan and carboplatin in patients with ovarian cancer not suitable for treatment with cisplatin

ISRCTN ISRCTN88345833
DOI https://doi.org/10.1186/ISRCTN88345833
Secondary identifying numbers G44
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
04/01/2012
Recruitment status
Stopped
Overall study status
Stopped
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOvarian cancer
Intervention1. Carboplatin: 6 x (glomerular filtration rate (GFR)+ 25) mg intravvenous every 28 days for six cycles
2. Treosulfan: 7 g/m2 intravenous every 28 days for six cycles
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)treosulfan and carboplatin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1993
Completion date15/07/1998
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Not considered for cisplatin ≥75 mg/m2
2. Stages Ic-IV
3. Histologically proven epithelial ovarian cancer
4. Life expectancy .3 months
5. World Health Organisation (WHO) Performance status 0-3
6. Creatinine clearance ≥20 ml/min White Blood Cell (WBC) Count ≥3.5 x 10^9/l Platelets ≥100 x 10^9/l
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1993
Date of final enrolment15/07/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2006 Yes No