Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE13
Study information
Scientific title
Acronym
Study hypothesis
Determine whether treatment with the intensive regimen BOP/VIP-B is more effective than BEP/P.
To determine the effect of G-CSF on the proportion of patients receiving full dose intensity of combination chemotherapy with either regimen.
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
Metastatic teratoma
Intervention
Arm 1 - Without granulocyte colony stimulating factor (G-CSF), BEP/EP.
Arm 2 - Without G-CSF, BOP/VIP-B.
Arm 3 - With G-CSF, BEP/EP.
Arm 4 - With G-CSF, BOP/VIP-B.
Intervention type
Drug
Phase
Not Specified
Drug names
Several
Primary outcome measures
Progression-free survival
Secondary outcome measures
Response rate, overall survival
Overall trial start date
01/02/1991
Overall trial end date
31/12/1994
Reason abandoned
Eligibility
Participant inclusion criteria
Histologically proven non-seminomatous germ cell tumour
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
154
Participant exclusion criteria
Previous radiotherapy or chemotherapy
Recruitment start date
01/02/1991
Recruitment end date
31/12/1994
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 (MRC) (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