Contact information
Type
Scientific
Primary contact
Mrs Pat Cook
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
pat.cook@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE09
Study information
Scientific title
Acronym
Study hypothesis
To define equivalent activity and lower toxicity of combination chemotherapy containing carboplatin rather than cisplatin
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
Cancer
Intervention
Arm 1 - 4 cycles BEP.
Arm 2 - 4 cycles CEB.
Intervention type
Drug
Phase
Not Specified
Drug names
Carboplatin
Primary outcome measures
Complete remission on chemotherapy or chemotherapy + surgery. Progression-free survival. Survival, toxicity.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1989
Overall trial end date
31/12/1993
Reason abandoned
Eligibility
Participant inclusion criteria
Histologically confirmed non-seminomatous germ cell tumour of testis or combined seminoma/teratoma or seminoma with unequivocal raised serum alpha feto protein concentration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
450
Participant exclusion criteria
Previous chemotherapy.
Recruitment start date
01/06/1989
Recruitment end date
31/12/1993
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Results - basic reporting
Publication summary
Publication citations
-
Results
Horwich A, Sleijfer DT, Fosså SD, Kaye SB, Oliver RT, Cullen MH, Mead GM, de Wit R, de Mulder PH, Dearnaley DP, Cook PA, Sylvester RJ, Stenning SP, Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial., J. Clin. Oncol., 1997, 15, 5, 1844-1852.