Contact information
Type
Scientific
Primary contact
Dr Pat Cook
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 20 7670 4600
pat.cook@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE03
Study information
Scientific title
Study of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular cancer
Acronym
Study hypothesis
Investigate whether the toxicity of chemotherapy in patients with small volume metastasis and low blood marker concentrations can be decreased by the reduction of the dose of Bleomycin given in the BEP regimen without loss of therapeutic activity.
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
Cancer
Intervention
Arm 1: Bleomycin 30 mg x 3 per course, BEP x 4
Arm 2: Bleomycin 30 mg per course, BEP x 4
Intervention type
Drug
Phase
Phase II
Drug names
Bleomycin, etoposide, cisplatin (platinum)
Primary outcome measure
Toxicity/response
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1986
Overall trial end date
31/12/1986
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Histologically proven non-seminomatous testicular cancer
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
44
Participant exclusion criteria
Previous radiotherapy or chemotherapy
Recruitment start date
01/01/1986
Recruitment end date
31/12/1986
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
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