Contact information
Type
Scientific
Primary contact
Dr PM Wilkinson
ORCID ID
Contact details
Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 0161 446 3261
Peter.Wilkinson@christie-tr.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0063044257
Study information
Scientific title
Treatment of high risk testicular tumour with high dose chemotherapy with peripheral blood stem cells
Acronym
Study hypothesis
To assess the efficacy of high dose chemotherapy with peripheral blood stem cells to see if the response rate is improved compared to conventional therapy.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Testicular
Intervention
High dose chemotherapy with peripheral blood stem cells vs no high dose
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Time to white cell and platelet recovery
2. Confirmation of response
3. Assessment of toxicity by standard World Health Organisation (WHO) grades
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/1994
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with histological proven non-seminomatous germ cell tumours
2. High risk factors as defined by MRC prognostic group
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
6
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/1994
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Christie Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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