Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003420
Protocol/serial number
TE08
Study information
Scientific title
Acronym
Study hypothesis
To assess the value of frequent abdominal and chest CT scans in the follow-up of patients with stage I non-seminomatous germ cell tumours (NSGCT) who are on a surveillance programme. After baseline scans confirming stage I disease, patients will be randomised between two and five further CT scans during their follow up, with the nature and frequency of all other investigations remaining constant.
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
1. One group receives two CT scans
2. The other group receives five CT scans
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Stage of the disease at relapse (IGCC Classification), time from entry to detection of relapse.
Secondary outcome measures
Overall survival, identification of the first investigation or sign prompting diagnosis of relapse, incidence of second malignancies and balance of costs of treatment determined through health economics study
Overall trial start date
01/12/1997
Overall trial end date
30/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically confirmed stage I non-seminomatous germ cell tumour of the testis
2. Patients must be able to attend for regular surveillance
3. The interval between orchidectomy and randomisation should not exceed 8 weeks
4. No co-existent or previously treated malignant disease, except successfully treated non-melanotic skin cancer
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
900
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1997
Recruitment end date
30/04/2003
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
private sector organisation
Funding Body Subtype
other non-profit
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
Rustin GJ, Mead GM, Stenning SP, Vasey PA, Aass N, Huddart RA, Sokal MP, Joffe JK, Harland SJ, Kirk SJ, , Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group., J. Clin. Oncol., 2007, 25, 11, 1310-1315, doi: 10.1200/JCO.2006.08.4889.