Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G44
Study information
Scientific title
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ovarian cancer
Intervention
1. 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 type
Drug
Phase
Not Specified
Drug names
treosulfan and carboplatin
Primary outcome measure
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
15/07/1998
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Not Specified
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
15/07/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16337372
Publication citations
-
Results
Reed NS, Poole CJ, Coleman R, Parkin D, Graham JD, Kaye SB, Ostrowski J, Duncan I, Paul J, Hay A, , A randomised comparison of treosulfan and carboplatin in patients with ovarian cancer: a study by the Scottish Gynaecological Cancer Trials Group (SGCTG)., Eur. J. Cancer, 2006, 42, 2, 179-185, doi: 10.1016/j.ejca.2005.09.022.