Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE12
Study information
Scientific title
Acronym
Study hypothesis
Compare the efficacy of carboplatin with a combination of etoposide and cisplatin in the treatment of advanced metastatic seminoma.
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 of carboplatin.
Arm 2 - 4 cycles of cisplatin/etoposide.
Intervention type
Drug
Phase
Not Specified
Drug names
Carboplatin versus Etoposide / Cisplatin
Primary outcome measure
Progression-free survival
Secondary outcome measures
Response, survival, toxicity.
Overall trial start date
01/08/1990
Overall trial end date
31/12/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Histologically verified testicular/extra-gonadal pure seminoma
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
112
Participant exclusion criteria
Previous chemotherapy.
Recruitment start date
01/08/1990
Recruitment end date
31/12/1995
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
Basic results (scientific)
Publication list
Publication citations
-
Results
Horwich A, Oliver RT, Wilkinson PM, Mead GM, Harland SJ, Cullen MH, Roberts JT, Fossa SD, Dearnaley DP, Lallemand E, Stenning SP, , A medical research council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma. MRC Testicular Tumour Working Party., Br. J. Cancer, 2000, 83, 12, 1623-1629, doi: 10.1054/bjoc.2000.1498.